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Glenmark Pharma Gets FDA's Tentative Approval for New Drug, Shares Rise

Shares of Glenmark Pharmaceuticals gained as much as 2.5 per cent to Rs 954.45 after the pharma company said that it has received tentative US regulator's tentative approval for its Dronedarone tablets 400 mg, the generic version of Multaq tablets of Sanofi-Aventis US LLC.
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Glenmark Pharma Gets FDA's Tentative Approval for New Drug, Shares Rise
Shares of Glenmark Pharmaceuticals gained as much as 2.5 per cent to Rs 954.45 after the pharma company said that it has received tentative US regulator's tentative approval for its Dronedarone tablets 400 mg, the generic version of Multaq tablets of Sanofi-Aventis US LLC.

Multaq is used to treat certain heart rhythm disorders.

Tentative approval means that the drug meets all the safety, quality and efficacy requirements of the US Food and Drug Administrator but can't be marketed in US due to existing patent protections.

Glenmark said that it expects to be eligible for 180 days of generic drug exclusivity upon final approval from the US regulator.

Glenmark also said that it remains involved in a patent litigation in the U.S. District Court for the District of Delaware, wherein Sanofi and Sanofi-Aventis U.S., LLC has asserted its patents.

According to IMS Health sales data for the 12-month period ending November 2015, the Multaq of Sanofi-Aventis achieved annual sales of approximately $425.7 million, Glenmark said in a statement.

Shares of Glenmark Pharma, however, gave up gains and ended 2.71 per cent lower at Rs 907.5 on the BSE, whose benchmark Sensex finished down 0.68 per cent.

 

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