Glenmark Pharma gets USFDA nod for generic drug

Glenmark Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic nicardipine hydrochloride capsules used to treat high blood pressure and to control angina.

The approval granted by the US Food & Drug Administration (USFDA) is for bicardipine hydrochloride capsules of strengths 20 mg and 30 mg, Glenmark said in a statement.

These are the generic version of Cardene capsules 20 mg and 30 mg of Chiesi USA, Inc, it added.

These will be distributed in the US by Glenmark Pharmaceuticals Inc, USA, the company said.

For the 12-month period ended October 2022, the Cardene capsules 20 mg and 30 mg achieved annual sales of approximately USD 10.9 million, the company said citing IQVIATM sales data.