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( As on 15/06/2021 11:18)

Cipla's Avenue Therapeutics gets USFDAs Complete Response Letter for IV tramadol

The drug major's subsidiary, Avenue Therapeutics Inc. has received a second Complete Response Letter (CRL) from the US drug regulator regarding its New Drug Application (NDA) seeking approval for IV tramadol.

Avenue Therapeutics Inc is the company focused on the development of intravenous (IV) tramadol for the US market. 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 there is insufficient information to support that IV tramadol in combination with other analgesics is safe and effective for the intended patient population. The Food and Drug Administration (FDA) did not identify any Chemistry, Manufacturing and Controls (CMC) issues in this CRL.

Avenue Therapeutics disagreed with the FDA's interpretation of the data in the NDA and intends to continue to pursue regulatory approval for IV tramadol.