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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="3" face="Times New Roman" style="font-size:12.0pt;font-weight:bold;">UNITED STATES</font></b></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="3" face="Times New Roman" style="font-size:12.0pt;font-weight:bold;">SECURITIES AND EXCHANGE COMMISSION</font></b></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="3" face="Times New Roman" style="font-size:12.0pt;font-weight:bold;">WASHINGTON, DC 20549</font></b></p>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="3" face="Times New Roman" style="font-size:12.0pt;font-weight:bold;">FORM&nbsp;8-K</font></b></p>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="3" face="Times New Roman" style="font-size:12.0pt;font-weight:bold;">CURRENT REPORT PURSUANT</font></b></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="3" face="Times New Roman" style="font-size:12.0pt;font-weight:bold;">TO SECTION&nbsp;13 OR 15(d)&nbsp;OF THE</font></b></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="3" face="Times New Roman" style="font-size:12.0pt;font-weight:bold;">SECURITIES EXCHANGE ACT OF 1934</font></b></p>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">Date of report (Date of earliest event reported): September&nbsp;23, 2013</font></p>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><u><font size="3" face="Times New Roman" style="font-size:12.0pt;">AMAG PHARMACEUTICALS,&nbsp;INC.</font></u></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">(Exact name of registrant as specified in its charter)</font></p>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><u><font size="3" face="Times New Roman" style="font-size:12.0pt;">Delaware</font></u></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">(State or other jurisdiction of incorporation)</font></p>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">001-10865</font></p>    </td>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">04-2742593</font></p>    </td>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">(IRS Employer   Identification No.)</font></p>    </td>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">1100 Winter St.</font></p>    </td>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">Waltham, Massachusetts</font></p>    </td>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><u><font size="3" face="Times New Roman" style="font-size:12.0pt;">02451</font></u></p>    </td>
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<p align="center" style="background:white;margin:0in 0in .0001pt;text-align:center;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>
<p align="center" style="background:white;margin:0in 0in .0001pt;text-align:center;"><u><font size="3" face="Times New Roman" style="font-size:12.0pt;">(617) 498-3300</font></u></p>
<p align="center" style="background:white;margin:0in 0in 12.0pt;text-align:center;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">(Registrant&#146;s telephone number, including area code)</font></p>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">100 Hayden Avenue</font></p>    </td>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">Lexington,   Massachusetts, 02421</font></p>    </td>
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<p style="margin:0in 0in .0001pt;text-indent:.5in;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">Check the appropriate box below if the Form&nbsp;8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:</font></p>
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<p style="font-size:12.0pt;margin:0in 0in .0001pt;"><font size="3" face="Wingdings" style="font-size:12.0pt;">&#168;</font>&#160; Written communications pursuant to Rule&nbsp;425 under the Securities Act (17 CFR 230.425)</p>
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<p style="font-size:12.0pt;margin:0in 0in .0001pt;"><font size="3" face="Wingdings" style="font-size:12.0pt;">&#168;</font>&#160; Soliciting material pursuant to Rule&nbsp;14a-12 under the Exchange Act (17 CFR 240.14a-12)</p>
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<p style="font-size:12.0pt;margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="3" face="Wingdings" style="font-size:12.0pt;">&#168;</font>&#160; Pre-commencement communications pursuant to Rule&nbsp;14d-2(b)&nbsp;under the Exchange Act (17 CFR 240.14d-2(b))</p>
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<p style="margin:0in 0in .0001pt;"><b><font size="3" face="Times New Roman" style="font-size:12.0pt;font-weight:bold;">Item 8.01.&#160; Other Events.</font></b></p>
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>
<p style="font-size:12.0pt;margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">On December&nbsp;21, 2012, AMAG Pharmaceuticals,&nbsp;Inc. (the &#147;<i>Company</i>&#148;) submitted to the U.S. Food and Drug Administration (the &#147;<i>FDA</i>&#148;) a supplemental New Drug Application (the &#147;<i>sNDA</i>&#148;) under section 505(b)&nbsp;of the Federal Food, Drug, and Cosmetic Act for Feraheme</font><font size="1" style="font-size:8.0pt;position:relative;top:-4.0pt;">&#174;</font>&#160;(ferumoxytol) Injection, 510 mg.&#160; The sNDA seeks approval for a broader indication for Feraheme for the treatment of iron deficiency anemia (&#147;<i>IDA</i>&#148;) in adult patients who have failed or could not use oral iron.&#160; On September&nbsp;23, 2013, the Company received a notification from the FDA (the &#147;<i>Notification</i>&#148;) stating that, as part of its ongoing review of the Company&#146;s sNDA, the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments by September&nbsp;23, 2013, a target date previously communicated by the FDA in a letter dated March&nbsp;5, 2013.&#160; The FDA stated that the Notification does not reflect a final decision on the information under review.</p>
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">The Company plans to work with the FDA to resolve any outstanding issues.&#160; Potential topics for discussions with the FDA could include, without limitation, technical and scientific information, labeling, post-marketing requirements/commitments, risk evaluation and mitigation strategies in connection with the current chronic kidney disease and the proposed IDA populations, new studies or re-analyses of existing data.&#160; Under the guidelines of the Prescription Drug User Fee Act (&#147;<i>PDUFA</i>&#148;), the FDA has set October&nbsp;21, 2013 as a target date for a decision on the sNDA.</font></p>
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">A copy of the Notification is attached hereto as Exhibit&nbsp;99.1 and is incorporated herein by reference.</font></p>
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">By filing this information, the Company makes no admission as to the materiality of any information in this report.&#160; The information contained in this report is intended to be considered in the context of the Company&#146;s filings with the U.S. Securities and Exchange Commission (the &#147;<i>Commission</i>&#148;) and other public announcements that the Company makes, by press release or otherwise, from time to time.&#160; The Company undertakes no duty or obligation to publicly update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate.&#160; Any such updating may be made through the filing of other reports or documents with the Commission, through press releases or through other public disclosure.</font></p>
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">This report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws.&#160; Any statements contained herein which do not describe historical facts, including but not limited to statements regarding the approval of the sNDA for a broader patient population, the Company&#146;s expectations with regard to discussions and plans with the FDA and expectations as to the PDUFA date are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.</font></p>
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">Such risks and uncertainties include: (1)&nbsp;uncertainties regarding the Company&#146;s and Takeda Pharmaceutical&#146;s ability to successfully compete in the intravenous iron replacement market both in the U.S. and outside the U.S., including the EU, (2)&nbsp;uncertainties regarding the Company&#146;s ability to compete in the oral mucositis market in the U.S., (3)&nbsp;uncertainties regarding the</font></p>
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">Company&#146;s ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme/Rienso in the broader iron deficiency anemia indication both in the U.S. and outside of the U.S., including the EU, (4)&nbsp;the possibility that significant safety or drug interaction problems could arise with respect to Feraheme/Rienso, (5)&nbsp;uncertainties regarding the manufacture of Feraheme/Rienso or MuGard, (6)&nbsp;uncertainties relating to the Company&#146;s patents and proprietary rights both in the U.S. and outside the U.S., (7)&nbsp;the risk of an Abbreviated New Drug Application (ANDA) filing following the FDA&#146;s recently published draft bioequivalence recommendation for ferumoxytol, and (8)&nbsp;other risks identified in the Company&#146;s Commission filings, including the Company&#146;s Quarterly Report on Form&nbsp;10-Q for the quarter ended June&nbsp;30, 2013 and subsequent filings with the Commission.&#160; The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.</font></p>
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.</font></p>
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><b><font size="3" face="Times New Roman" style="font-size:12.0pt;font-weight:bold;">Item 9.01.&#160; Financial Statements and Exhibits.</font></b></p>
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">(d)&nbsp; Exhibits.</font></p>
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">99.1&#160;&#160;&#160;&#160; FDA Notification from the Office of Hematology and Oncology Products received September&nbsp;23, 2013</font></p>
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="3" face="Times New Roman" style="font-size:12.0pt;font-weight:bold;">SIGNATURES</font></b></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;text-indent:.5in;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.</font></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt 261.0pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt 261.0pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>
<table border="0" cellspacing="0" cellpadding="0" width="100%" style="border-collapse:collapse;width:100.0%;">
<tr>
<td width="57%" valign="top" style="padding:0in 0in 0in 0in;width:57.26%;">
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:1.0pt;">&nbsp;</font></p>    </td>
<td width="42%" colspan="2" valign="top" style="padding:0in 0in 0in 0in;width:42.74%;">
<p style="margin:0in 0in .0001pt;"><b><font size="3" face="Times New Roman" style="font-size:12.0pt;font-weight:bold;">AMAG   PHARMACEUTICALS,&nbsp;INC.</font></b></p>    </td>   </tr>
<tr>
<td width="57%" valign="top" style="padding:0in 0in 0in 0in;width:57.26%;">
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>    </td>
<td width="42%" colspan="2" valign="top" style="padding:0in 0in 0in 0in;width:42.74%;">
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>    </td>   </tr>
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<td width="57%" valign="top" style="padding:0in 0in 0in 0in;width:57.26%;">
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:1.0pt;">&nbsp;</font></p>    </td>
<td width="4%" valign="top" style="padding:0in 0in 0in 0in;width:4.0%;">
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">By:</font></p>    </td>
<td width="38%" valign="top" style="border:none;border-bottom:solid windowtext 1.0pt;padding:0in 0in 0in 0in;width:38.74%;">
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;/s/   William K. Heiden</font></p>    </td>   </tr>
<tr>
<td width="57%" valign="top" style="padding:0in 0in 0in 0in;width:57.26%;">
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:1.0pt;">&nbsp;</font></p>    </td>
<td width="42%" colspan="2" valign="top" style="padding:0in 0in 0in 0in;width:42.74%;">
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">President and Chief   Executive Officer</font></p>    </td>   </tr>
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<td width="57%" valign="top" style="padding:0in 0in 0in 0in;width:57.26%;">
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>    </td>
<td width="42%" colspan="2" valign="top" style="padding:0in 0in 0in 0in;width:42.74%;">
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>    </td>   </tr>
<tr>
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<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>    </td>
<td width="42%" colspan="2" valign="top" style="padding:0in 0in 0in 0in;width:42.74%;">
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>    </td>   </tr>
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<td width="57%" valign="top" style="padding:0in 0in 0in 0in;width:57.26%;">
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>    </td>
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<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>    </td>   </tr>
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<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:1.0pt;">&nbsp;</font></p>    </td>
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<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">Date:   September&nbsp;25, 2013</font></p>    </td>   </tr>  </table>
<p style="margin:0in 0in .0001pt 261.0pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="3" face="Times New Roman" style="font-size:12.0pt;font-weight:bold;">EXHIBIT&nbsp;INDEX</font></b></p>
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>
<table border="0" cellspacing="0" cellpadding="0" width="90%" style="border-collapse:collapse;width:90.0%;">
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<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">Exhibit&nbsp; Number</font></p>    </td>
<td width="2%" valign="bottom" style="padding:0in 0in 0in 0in;width:2.8%;">
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:1.0pt;">&nbsp;</font></p>    </td>
<td width="77%" valign="top" style="border:none;border-bottom:solid windowtext 1.0pt;padding:0in 0in 0in 0in;width:77.44%;">
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">Description</font></p>    </td>   </tr>
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<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>    </td>
<td width="2%" valign="bottom" style="padding:0in 0in 0in 0in;width:2.8%;">
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>    </td>
<td width="77%" valign="top" style="border:none;padding:0in 0in 0in 0in;width:77.44%;">
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>    </td>   </tr>
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<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">99.1</font></p>    </td>
<td width="2%" valign="bottom" style="padding:0in 0in 0in 0in;width:2.8%;">
<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:1.0pt;">&nbsp;</font></p>    </td>
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<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">FDA Notification from   the Office of Hematology and Oncology Products received September&nbsp;23,   2013</font></p>    </td>   </tr>  </table>
<p align="right" style="margin:0in 0in .0001pt;text-align:right;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="3" face="Times New Roman" style="font-size:12.0pt;">&nbsp;</font></p>
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{"company-data": {"conformed-name": "AMAG PHARMACEUTICALS INC.", "cik": "0000792977", "assigned-sic": "2834", "irs-number": "042742593", "state-of-incorporation": "DE", "fiscal-year-end": "1231"}, "filing-values": {"form-type": "8-K", "act": "34", "file-number": "001-10865", "film-number": "131113342"}, "business-address": {"street1": "100 HAYDEN AVENUE", "city": "LEXINGTON", "state": "MA", "zip": "02421", "phone": "6174983300"}, "mail-address": {"street1": "100 HAYDEN AVENUE", "city": "LEXINGTON", "state": "MA", "zip": "02421"}, "former-company": {"former-conformed-name": "ADVANCED MAGNETICS INC", "date-changed": "19920703"}}
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): September 23, 2013
AMAG PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
001-10865
04-2742593
(Commission File   Number)
(IRS Employer   Identification No.)
1100 Winter St.
Waltham, Massachusetts
02451
(Address of   principal executive offices)
(Zip Code)
(617) 498-3300
(Registrant's telephone number, including area code)
100 Hayden Avenue
Lexington,   Massachusetts, 02421
(Former address, if   changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01.  Other Events.
On December 21, 2012, AMAG Pharmaceuticals, Inc. (the "
Company
") submitted to the U.S. Food and Drug Administration (the "
FDA
") a supplemental New Drug Application (the "
sNDA
") under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Feraheme
®
(ferumoxytol) Injection, 510 mg.  The sNDA seeks approval for a broader indication for Feraheme for the treatment of iron deficiency anemia ("
IDA
") in adult patients who have failed or could not use oral iron.  On September 23, 2013, the Company received a notification from the FDA (the "
Notification
") stating that, as part of its ongoing review of the Company's sNDA, the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments by September 23, 2013, a target date previously communicated by the FDA in a letter dated March 5, 2013.  The FDA stated that the Notification does not reflect a final decision on the information under review.
The Company plans to work with the FDA to resolve any outstanding issues.  Potential topics for discussions with the FDA could include, without limitation, technical and scientific information, labeling, post-marketing requirements/commitments, risk evaluation and mitigation strategies in connection with the current chronic kidney disease and the proposed IDA populations, new studies or re-analyses of existing data.  Under the guidelines of the Prescription Drug User Fee Act ("
PDUFA
"), the FDA has set October 21, 2013 as a target date for a decision on the sNDA.
A copy of the Notification is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
By filing this information, the Company makes no admission as to the materiality of any information in this report.  The information contained in this report is intended to be considered in the context of the Company's filings with the U.S. Securities and Exchange Commission (the "
Commission
") and other public announcements that the Company makes, by press release or otherwise, from time to time.  The Company undertakes no duty or obligation to publicly update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate.  Any such updating may be made through the filing of other reports or documents with the Commission, through press releases or through other public disclosure.
This report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws.  Any statements contained herein which do not describe historical facts, including but not limited to statements regarding the approval of the sNDA for a broader patient population, the Company's expectations with regard to discussions and plans with the FDA and expectations as to the PDUFA date are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.
Such risks and uncertainties include: (1) uncertainties regarding the Company's and Takeda Pharmaceutical's ability to successfully compete in the intravenous iron replacement market both in the U.S. and outside the U.S., including the EU, (2) uncertainties regarding the Company's ability to compete in the oral mucositis market in the U.S., (3) uncertainties regarding the
Company's ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme/Rienso in the broader iron deficiency anemia indication both in the U.S. and outside of the U.S., including the EU, (4) the possibility that significant safety or drug interaction problems could arise with respect to Feraheme/Rienso, (5) uncertainties regarding the manufacture of Feraheme/Rienso or MuGard, (6) uncertainties relating to the Company's patents and proprietary rights both in the U.S. and outside the U.S., (7) the risk of an Abbreviated New Drug Application (ANDA) filing following the FDA's recently published draft bioequivalence recommendation for ferumoxytol, and (8) other risks identified in the Company's Commission filings, including the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2013 and subsequent filings with the Commission.  The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.
The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Item 9.01.  Financial Statements and Exhibits.
(d)  Exhibits.
99.1     FDA Notification from the Office of Hematology and Oncology Products received September 23, 2013
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
AMAG   PHARMACEUTICALS, INC.
By:
/s/   William K. Heiden
President and Chief   Executive Officer
Date:   September 25, 2013
EXHIBIT INDEX
Exhibit  Number
Description
99.1
FDA Notification from   the Office of Hematology and Oncology Products received September 23,   2013