ATRS: FDA Issues Makena Withdrawal - Appeal Possible
Oct 6, 2020 12:32:14 GMT
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Post by icemandios on Oct 6, 2020 12:32:14 GMT
Item 7.01. Regulation FD Disclosure.
On October 5, 2020, AMAG Pharmaceuticals, Inc. (“AMAG,” “we” or the “Company”), issued a press release, a copy of which is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
Item 8.01. Other Events.
On October 5, 2020, we received from the Center for Drug Evaluation and Research (“CDER”) of the Food and Drug Administration (“FDA”) a proposal to withdraw marketing approval of Makena (hydroxyprogesterone caproate injection) and notice of opportunity for a hearing (the “Notice”).
The Notice provides AMAG with the opportunity to request a hearing within 15 days of receipt of the Notice and invites holders of the approved generics of Makena to submit comments. If AMAG files a timely request for a hearing, we must, within 30 days of receipt of the Notice, submit data, information and analyses to demonstrate that there is a genuine and substantial issue of material fact that requires a hearing. The FDA Commissioner would decide whether to grant AMAG’s request for a hearing and, if granted, would conduct such hearing and thereafter decide whether to withdraw approval of Makena.
The Makena label remains unchanged and during the pendency of this process, which the FDA has indicated in the frequently asked questions referred to in CDER’s statement published on October 5, 2020 can take months if a hearing is pursued, Makena and the approved generic formulations of Makena will remain on the market until the Commissioner makes a final decision about these products. AMAG is evaluating the full range of potential options.