BUSINESS

Glenmark Pharmaceuticals Gets USFDA Approval to Market its Drug

Glenmark's Ropivacaine Hydrochloride Injection is only approved for the indications specified on the approved label.
Glenmark's Ropivacaine Hydrochloride Injection is only approved for the indications specified on the approved label.

The Mumbai-based drug maker Glenmark Pharmaceuticals on 1 August said it had received the nod from the US Food and Drug Administration (USFDA) to market its generic diabetes drug in the American market.

The company said in a statement that they have received final approval from the US health regulator for their Saxagliptin Tablets (2.5 mg and 5 mg), the generic version of AstraZeneca’s Onglyza1 tablets.

Glenmark Pharmaceuticals said that they currently have 49 new drug applications that are pending approval, and their portfolio consists of 184 drugs authorized for distribution in the US market.

According to the latest sales data by IQVIATM, for 1 year, the Onglyza tablets (2.5 mg and 5 mg) achieved annual sales of around USD 100.7 million.

A board of directors meeting is set to happen on 11 August with an agenda to discuss and approve the company’s financial results for the April-June quarter.

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