Cipla’s ‘Tramadol’ unsafe for patient
Mumbai-based drug maker Cipla’s subsidiary Avenue Therapeutics fails to get a nod from USFDA for its new drug application for intravenous (IV) pain killer Tramadol, citing safety concerns. FDA states it cannot approve the application in its present form as it is not safe for the intended patient.
The drug major’s step-down US-based subsidiary has received a complete response letter (CRL) from the US drug regulator for IV Trambol.
The USFDA requires an adequate terminal sterilization validation prior to NDA approval, which is planned for later this quarter.
Cipla believes that it’s extensive clinical database strongly supports the value of treatment with IV tramadol as an effective alternative to intravenous Schedule II conventional opioids. It firmly stand behind the safety data in NDA and the ultimate approvability of IV tramadol.
The step-down subsidiary 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 0.93% to Rs 806 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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