Cipla gets USFDA approval for anti-hepatitis B drug; shares gain

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26 Aug, 2025 12:21

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Moneycontrol BureauShares of pharma major Cipla rose 1.5 percent intraday Thursday on final approval from the US health regulator for anti-hepatitis B drug.The company has received final approval for its abbreviated new drug application (ANDA) for Entecavir tablets USP 0.5 mg and 1 mg, from the United States Food and Drug Administration (USFDA).Entecavir tablets are AB-rated generic equivalents of Bristol-Myers Squibb’s Baraclude tablets 0.5 mg and 1 mg.These tablets are a hepatitis B virus nucleoside analog reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection.According to IMS Health, Baraclude tablets and generic equivalents had US sales of approximately USD 206 million for the 12-month period ending October 2016.The product will cater to the US market and will be commercially available in the coming weeks, it said. At 12:36 hrs Cipla was quoting at Rs 577.55, up Rs 7.15, or 1.25 percent on the BSE.Posted by Rakesh Patil