The drug major said that its step-down US-based subsidiary received complete response letter (CRL) from the US drug regulator for IV Trambol.
CRL stated that the application for IV tramadol cannot be approved in its present form. The drug, intended to treat patients in acute pain who require an opioid, is not safe for the intended patient population. The USFDA requires an adequate terminal sterilization validation prior to NDA approval, which is planned for later this quarter.
We believe that our extensive clinical database strongly supports the value of treatment with IV tramadol as an effective alternative to intravenous Schedule II conventional opioids. We firmly stand behind the safety data in our NDA and the ultimate approvability of IV tramadol, said Lucy Lu, MD, president and chief executive officer of Avenue Therapeutics. We will request a meeting with the FDA as soon as possible and are committed to working closely with the agency to resolve these issues in order to bring this important medicine to patients and clinicians in the US.
Shares of Cipla fell 0.09% to Rs 814 on BSE.
The drug major's net profit rose 21.4% to Rs 571.43 crore on 9.8% increase in net sales to Rs 4,276.89 crore in Q1 FY21 over Q1 FY20. Cipla is a global pharmaceutical company focused on complex generics, and deepening its portfolio in the markets of India, South Africa, North America, and key regulated and emerging markets.
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