Lupin gets USFDA nod to launch generic form of Onfi for seizures

Pharma manufacturer Lupin said it has received approval from the US Food and Drug Administration to sell a generic equivalent of Lundbeck Pharma’s seizure drug Onfi.

Onfi Tablets, in 10 and 20 mg doses, have annual sales of $601.2 million in the US, making it one of the bigger drugs in the market.

Clobazam, the generic name of Onfi, is an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. 

Lennox-Gastaut syndrome (LGS) is a rare and severe kind of epilepsy that starts in childhood.

Affected individuals have multiple types of seizures. Epilepsy begins in early childhood, usually between ages 3 and 5. The most common seizure type is tonic seizures, which cause the muscles to stiffen (contract) uncontrollably. 

Lupin is one of the world’s biggest makers of generic drugs, and sells both branded & generic formulations, biotechnology products and pharmaceutical ingredients globally.

It is the world’s biggest manufacturer of anti-TB medicines and focuses on cardiovascular, diabetology, asthma, pediatric, CNS, GI, anti-infective and NSAID segments of the pharma market.