Glenmark gets USFDA nod for generic ophthalmic solution

The final approval by the US Food & Drug Administration (USFDA) is for brimonidine tartrate and timolol maleate ophthalmic solution of strength 0.2%/0.5%.

New Delhi: Glenmark Pharmaceuticals Ltd on Friday said it has received final approval from the US health regulator for its generic brimonidine tartrate and timolol maleate ophthalmic solution indicated in the treatment increased pressure in the eye caused by glaucoma or other conditions.

The final approval by the US Food & Drug Administration (USFDA) is for brimonidine tartrate and timolol maleate ophthalmic solution of strength 0.2 per cent/0.5 per cent, Glenmark said in a statement.

The company's brimonidine tartrate and timolol maleate ophthalmic solution, 0.2 per cent/0.5 per cent has been determined by the USFDA to be bioequivalent and therapeutically equivalent to Combigan ophthalmic solution, 0.2 per cent/0.5 per cent of AbbVie, Inc, it added.

The solution will be distributed in the US by Glenmark Pharmaceuticals Inc, USA, it added.

Combigan ophthalmic solution, 0.2 per cent/0.5 per cent achieved annual sales of approximately $290 million, the company said citing IQVIATM sales data for the 12-month period ended March 2024.