Fortress Biotech, Inc 8-K, filed Apr 13, 2021
Fortress Biotech, Inc. (FBIO)
About this 8-K
Fortress Biotech, Inc filed this 8-K on April 13, 2021.
Items reported
- Item 8.01: Other events
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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CURRENT REPORT
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Item 8.01. Other Events.
On April 13, 2021, Avenue Therapeutics, Inc. (“Avenue”), a Fortress Biotech Inc. partner company, announced that the Food and Drug Administration (the “FDA”) was still reviewing Avenue’s New Drug Application for IV tramadol (the “NDA”) and had not provided a decision regarding the NDA. In February 2021, the FDA indicated that Avenue’s resubmission of the NDA (the “Resubmission”) was a complete, class 1 response to the Complete Response Letter dated October 9, 2020, and that the Resubmission had been assigned a Prescription Drug User Fee Act goal date of April 12, 2021.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Fortress Biotech, Inc. | |
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(Registrant) | |
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Date: April 13, 2021
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| By: | /s/ Lindsay A. Rosenwald, M.D. | |
| Lindsay A. Rosenwald, M.D. | ||
| Chairman, President and Chief Executive Officer | ||