Glenmark Pharmaceuticals, Inc., USA, the wholly owned US subsidiary of Glenmark Pharmaceuticals Limited, received US FDA approval to market gabapentin oral tablets 600 mg and 800 mg.
Gabapentin belongs to a category of anti-convulsants and is prescribed to help control epileptic seizures. It is also widely used to relieve different kinds of pain and even psychiatric disorders. The drug enjoys a generic market size of USD 328 million.
Glenmark manufactures the drug at its solid-oral formulation facility at Goa and will commence shipments of gabapentin immediately, a company release said.
Gabapentin is the fourth ANDA filed by Glenmark from the Goa facility to receive US FDA approval after fluconazole, zonisamide and meloxicam. With this approval, Glenmark will have ten generics on the market including two controlled substances: Codeine Phosphate launched in June and morphine sulphate which is in the process of being launched.