UNITED STATES
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CURRENT REPORT
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Item 8.01. Other Events.
On June 14, 2021, Avenue Therapeutics, Inc. (“Avenue”), a Fortress Biotech, Inc. partner company, announced that Avenue had received a second Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (the “FDA”) regarding its New Drug Application seeking approval for IV tramadol. The CRL stated that the delayed and unpredictable onset of analgesia with IV tramadol does not support its benefit as a monotherapy to treat patients in acute pain and that there is insufficient information to support that IV tramadol in combination with other analgesics is safe and effective for the intended patient population. The FDA did not identify any Chemistry, Manufacturing and Controls issues in this second CRL. Avenue stated in the same announcement that it disagrees with the FDA’s interpretation of the data in the NDA and intends to continue to pursue regulatory approval for IV tramadol.
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.
| Fortress Biotech, Inc. | ||
| (Registrant) | ||
| Date: June 17, 2021 | ||
| By: | /s/ Lindsay A. Rosenwald, M.D. | |
| Lindsay A. Rosenwald, M.D. | ||
| Chairman, President and Chief Executive Officer | ||