Glenmark Gets USFDA approval for its generic glaucoma drug

17 May 2024 , 01:59 PM

Glenmark Pharmaceuticals Ltd announced on Friday that it has obtained final approval from the US Food & Drug Administration (USFDA) for its generic version of brimonidine tartrate and timolol maleate ophthalmic solution.

The approved solution is indicated for the treatment of increased pressure in the eye caused by glaucoma or other conditions.

At the time of writing, the shares of Glenmark Pharmaceuticals were trading at ₹1013.40 which is a 0.81% increase then the previous close. The stock has gained 66.44% in the last one year, and the stock has gained 18.44% gain since beginning of the year.

Glenmark’s brimonidine tartrate and timolol maleate ophthalmic solution have a strength of 0.2%/0.5%. The USFDA has determined Glenmark’s solution to be bioequivalent and therapeutically equivalent to Combigan ophthalmic solution, 0.2%/0.5%, which is manufactured by AbbVie, Inc.

Glenmark Pharmaceuticals Inc, USA will handle the distribution of the solution in the United States.

According to IQVIATM sales data for the 12-month period ended March 2024, Combigan ophthalmic solution, 0.2%/0.5%, achieved annual sales of approximately USD 290 million.

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