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Ranbaxy gets US FDA approval for Novartis’s Diovan generic

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Ranbaxy Laboratories has received approval from the US Food and Drug Administration (US FDA) to launch a cheaper copy of Novartis’ blood pressure pill Diovan, bolstering its outlook after a raft of regulatory bans for poor production quality at its India facilities dented investor sentiment.

Ranbaxy, which is in the process of being acquired by Indian drugmaker Sun Pharmaceutical Industries for $3.2 billion, will be the first company to launch a copy of Diovan in the US and will be entitled to six months of exclusivity to sell it.

Swiss drugmaker Novartis lost its patent rights to its once best-selling Diovan in the US at the end of 2012, but has avoided generic competition because of multiple production quality control problems at Ranbaxy.

All of Ranbaxy India-based plants have been barred by the FDA from exporting to the US due to violations of its good manufacturing practices. Ohm Laboratories, a unit of Ranbaxy in New Jersey, is allowed to make drugs for its largest market. The FDA over the past year has stepped up its scrutiny of drugmakers in India, which is the biggest supplier of medicines to the US.

Worries about quality control problems in India’s $15 billion drug industry came to the fore as multiple plants run by companies including Ranbaxy and Wockhardt were barred from exporting to the US.

Bill Winter, a Vice President at New Jersey-based Ohm Labs, said in a statement the Diovan generic would be launched “as soon as sufficient supplies are manufactured to meet the needs of the market.”


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