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Lupin gets Approval from USFDA for Birth-Control Pills

Lupin received approval from the US Food and Drug Administration for manufacturing and marketing Turqoz.

Lupin received approval from the US Food and Drug Administration for manufacturing and marketing Turqoz, a genetic equivalent of the pregnancy prevention pill Lo/Ovral-28.

The company said the announcement came at the closing time of the stock exchange.

Lupin informed the stock exchange that the American regulator has given it the approval for its “abbreviated new drug application for Turqoz® (Norgestrel and Ethinyl Estradiol Tablets USP) 0.3 mg/0.03 mg, to market a generic equivalent of Lo/Ovral-28 (Norgestrel and Ethinyl Estradiol Tablets) 0.3 mg/0.03 mg of Wyeth Pharmaceuticals LLC,”

The company said this new drug will be manufactured at Lupin’s Pithampur facility in India.

The Norgestrel and Ethinyl Estradiol tablets USP (RLD Lo/Ovral-28) have an annual estimated sale of $34 million in the US.

Lupin is yet to declare its numbers for the June quarter.

Before this, on July 24, Lupin received tentative approval for its Dolutegravir Lamivudine and Tenofovir Alafenamide tablets, used in the treatment of HIV.

Last week the USFDA approved the company’s new drug application for its chlorpromazine hydrochloride tablets used in treating mental disorders.

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