Item 7.01. Regulation FD Disclosure.
On
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
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
Forward Looking Statements This report contains forward-looking information about AMAG 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, among others, expectations about the path forward for Makena and our interactions with the FDA, as well as our plans following receipt of the Notice, including the possibility of requesting a hearing and the timeline for the process, including that Makena will remain on the market are based on management's current expectations and beliefs and 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, among others, risks and uncertainties
related to the path forward for Makena and our ability to successfully and
timely request a hearing and compile information that might be helpful to the
FDA; the possibility that our request for a hearing could be denied, or that the
FDA will withdraw marketing approval for Makena even following such a hearing,
the pursuit and planning of which could be costly and distracting to management;
and those other risks identified in AMAG's filings with the
AMAG 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.
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Item 9.01. Financial Statements and Exhibits.
(d) Exhibits. Exhibit Number Description 99.1 Press Release , dated October 5 , 2020 (furnished herewith) 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) 3
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