Lupin receives US FDA approval for Clobazam Tablets, 10 mg and 20 mg
Deepthi | Myequity news | Date : 17-12-2018 15:40:00 IST
Lupin has received approval for its Clobazam Tablets, 10 mg and 20 mg from the United States Food and Drug Administration (FDA) to market a generic version of Lundbeck Pharmaceuticals, LLC’s Onfi Tablets, 10 mg and 20 mg. About Lupin Limited
Lupin’s Clobazam Tablets, 10 mg and 20 mg is the generic version of Lundbeck Pharmaceuticals, LLC’s Onfi Tablets, 10 mg and 20 mg. It is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
Onfi Tablets, 10 mg and 20 mg had annual sales of approximately USD $601.2 million in the US (IQVIA MAT September 2018).
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.