Glenmark Pharmaceuticals Inc. USA has been granted final approval by the United States Food and Drug Administration (USFDA) for its Rufinamide tablets USP, 200 mg and 400 mg. These tablets are used to treat seizures caused by Lennox-Gastaut syndrome, a therapeutic equivalent of Banzel tablets of Eisai .
In a BSE filing, it said "Glenmark Pharmaceuticals, USA, has been granted final approval by the United States Food and Drug Administration (USFDA) for its Rufinamide tablets With respect to 180-day exclusivity. Glenmark was one of the first Abbreviated New Drug Application (ANDA) applicants to submit a substantially complete ANDA for Rufinamide 200 mg and 400 mg, with a paragraph IV certification. Therefore, Glenmark is eligible for 180 days of shared generic drug exclusivity for Rufinamide."
Glenmark Pharmaceuticals is a research-driven, global, integrated pharmaceutical organization headquartered at Mumbai, India. Glenmark has several molecules in various stages of clinical development and is primarily focused in the areas of Inflammation (asthma/COPD, rheumatoid arthritis etc.) and pain (neuropathic pain and inflammatory pain).