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Nov
23
ragupathyrenganathan
Strides Shasun gets USFDA nod to sell copycats of GSK’s Avodart
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Drug-maker Strides Shasun Ltd on Saturday said it has got approval from the US regulator to manufacture and sell the copycat versions of GlaxoSmithKline Plc’s blockbuster drug Avodart, known chemically as dutasteride, in the US.

Strides said it has won approval from the US Food and Drug Administration to use dutasteride capsules in strengths of 0.5 milligram. Dutasteride is used to shrink enlarged prostate and make it easier for men to urinate. It also lowers the need for surgery.

Strides Shasun is one among the first few generic makers to get the approval to sell Dutasteride that went off patent on Friday, the Bengaluru-based company said in a statement.

Earlier, Israel’s Teva Pharmaceutical Industries had got the exclusive right to launch the generic version of the drug in the US.

According to data from IMS Health, the US market for dutasteride capsules is worth about $470 million. Strides will make the drug in the company’s oral dosage facility in Bengaluru, it said.

Strides Shasun was formed by the merger of Bengaluru-based Strides Arcolab and Shasun Pharmaceuticals last year.

Courtesy – Live mint



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