Glenmark Pharma secures USFDA approval for generic anti-inflammatory drug

Glenmark gets USFDA nod for generic anti-inflammatory drug, an equivalent of Advil Dual Action with Acetaminophen Tablets. The drug will be distributed in the US market by Glenmark Therapeutics Inc, USA. The product is expected to generate significant revenue, as Advil Dual Action with Acetaminophen Tablets has annual sales of around USD 84.1 million. Glenmark has 195 approved products in the US and 52 ANDAs pending approval.

Glenmark Pharmaceuticals on Monday said it has received approval from the US health regulator to sell a generic version of anti-inflammatory drug in the American market.

The company has received approval from the US Food and Drug Administration (USFDA) for Acetaminophen and Ibuprofen tablets (250 mg/125 mg), the Mumbai-based drug maker said in a statement.

The company's product is the generic version of Haleon US Holdings, LLC's Advil 2 Dual Action with Acetaminophen Tablets, 250 mg/125 mg (OTC), it added.

Glenmark Therapeutics Inc, USA will distribute the drug in the US market, the drug maker said.

According to Nielsen syndicated data for the latest 52 weeks period ending March 23, 2024, the Advil Dual Action with Acetaminophen Tablets, 250 mg/125 mg achieved annual sales of around USD 84.1 million.

Glenmark said its current portfolio consists of 195 products authorised for distribution in the US marketplace and 52 abbreviated new drug applications (ANDAs) pending approval with the USFDA.

Shares of Glenmark Pharma were trading marginally up at Rs 1,080.45 apiece on the BSE.

(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)