Glenmark Pharma gets USFDA approval for seizure drug

Glenmark Pharmaceuticals said that it has received final approval by US Food & Drug Administration (USFDA) for Topiramate capsules.

The approved drug is bioequivalent and therapeutically equivalent to Topamax capsules of Janssen Pharmaceuticals and will be distributed in the U.S. by Glenmark Therapeutics Inc., USA.

Topiramate is used alone or with other medications to treat certain types of seizures including primary generalized tonic-clonic seizures and partial onset seizures. It is also used with other medications to control seizures in people who have Lennox-Gastaut syndrome (a disorder that causes seizures and developmental delays) as well as to prevent migraine headaches but not to relieve the pain of migraine headaches when they occur in adults and children 12 years of age and older.

 

According to IQVIA, the Topamax Capsules market achieved annual sales of approximately $21.9 million sales for the 12-month period ending May 2024.

Glenmark's current portfolio consists of 198 products authorized for distribution in the U.S. marketplace and 50 ANDA's pending approval with the U.S. FDA.

Glenmark Pharmaceuticals is a global innovation-driven pharmaceutical company with presence across specialty, generics and OTC businesses.

Glenmark Pharmaceuticals reported net loss of Rs 1,238.64 crore in Q4 FY24 as compared with net loss of Rs 549.49 crore in Q4 FY23. Revenue from operations increased 1.94% to Rs 3,016.00 crore in Q4 FY24 as compared with Rs 2,958.36 crore in Q4 FY23.

The scrip rose 0.20% to end at Rs 1,410.50 on Tuesday, 16 July 2024. The market is closed today on account of Moharram.

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