Glenmark gets USFDA final nod for anti-fungal ointment

By: | Published: June 24, 2016 12:01 PM

Glenmark Pharma has received final approval from the health regulator USFDA for anti-fungal ointment nystatin and triamcinolone acetonide.

The company also received tentative approval for Olmesartan medoxomil, used for the treatment of high bloodpressure. (Reuters)The company also received tentative approval for Olmesartan medoxomil, used for the treatment of high bloodpressure. (Reuters)

Glenmark Pharma has received final approval from the health regulator USFDA for anti-fungal ointment nystatin and triamcinolone acetonide.

The company also received tentative approval for Olmesartan medoxomil, used for the treatment of high bloodpressure.

“Glenmark Pharmaceuticals Inc, USA, has been granted final approval by the US Food and Drug Administration (USFDA) for nystatin and triamcinolone acetonide ointment USP, 1,00,000units/1 mg per gram,” it said in a BSE filing.

Nystatin and triamcinolone acetonide ointment is generic version of Taro while Olmesartan Medoxomil is generic version of Daiichi Sankyo’s Benicar.

Glenmark said it will market generic version of Benicar in the strengths of 5mg, 20mg and 40 mg upon receiving final approval.

According to IMS Health sales data for the 12 months to April 2016, Glenmark said Nystatin and triamcinolone acetonide ointment achieved annual sales of around USD 37.5 million.

While Benicar achieved annual sales of around USD 1.05 billion for the 12 months period ended April 2016.

The company’s current portfolio consists of 114 products authorised for distribution in the US marketplace and 62 ANDA pending approval with the USFDA.

Glenmark Pharmaceuticals shares were trading 4.15 per cent down at Rs 740.95 on BSE during the late morning trade.

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