Glenmark's Anti-Seizure Drug Approved By USFDA
The USFDA has approved Topiramate capsules with dosages of 15 milligrammes and 25 milligrammes, according to a company release.
Glenmark Pharmaceuticals Ltd. announced on Wednesday that the US health agency has given final approval to its generic Topiramate capsules, which are used to treat certain forms of seizures. The US Food and Drug Administration has approved Topiramate capsules with dosages of 15 milligrammes and 25 milligrammes, according to a company release.
Both capsules have been determined by the USFDA to be bioequivalent and therapeutically equivalent to Topamax capsules, 15 milligrams and 25 milligrams of Janssen Pharmaceuticals Inc., and will be distributed in the US by Glenmark Pharmaceuticals Inc., USA, it added.
Topamax Capsules, 15 milligrams and 25 milligrams market achieved annual sales of approximately USD 21.9 million, the company said citing IQVIATM sales data for the 12-month period ended May 2024.
The company said its current portfolio consists of 198 products authorised for distribution in the US marketplace and 50 Abbreviated New Drug Applications pending approval with the USFDA.
Glenmark Pharmaceuticals also said it continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
