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Hanmi Receives First Korea FDA Approval For Generic Of BMS’ Baraclude

 
• By Peter Chang

Hanmi is the first to clear regulatory hurdles to sell the country’s best-selling hepatitis B therapy after patent expiration in 2015, though the distinction doesn’t carry the same benefits as it once did.

SEOUL – Hanmi Pharmaceutical Co. Ltd. received regulatory approval for the sale of Cavir, the first generic of Bristol-Myers Squibb Co.’s hepatitis B therapy Baraclude (entecavir) to be available in South Korea when Baraclude loses domestic patent exclusivity in 2015.

Hanmi received Korea FDA approval Sept. 14 and told PharmAsia News it believed it was the first company to receive...

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