Lupin launches Clobazam oral suspension in US

The company has launched its Clobazam oral suspension 2.5mg/mL after having received approval from the United States Food and Drug Administration (USFDA) earlier, Lupin said in a statement.

New Delhi: Drug firm Lupin Friday said it has launched generic Clobazam oral suspension, used for the treatment of seizures associated with a severe form of epilepsy, in the US market.

The company has launched its Clobazam oral suspension 2.5mg/mL after having received approval from the United States Food and Drug Administration (USFDA) earlier, Lupin said in a statement.

This medication is used with other medications to help control seizures. It belongs to a class of medications called benzodiazepines, which act on the brain and nerves (central nervous system) to produce a calming effect. This drug works by enhancing the effects of a certain natural chemical in the body (GABA).

Read Also: Lupin gets FDA nod for Fluoxetine to treat depressive disorders

The product is the generic version of Lundbeck Pharmaceuticals LLC's Onfi Oral Suspension, 2.5mg/mL, it added.

As per IQVIA MAT December 2018 data, Clobazam oral suspension 2.5mg/mL had annual sales of USD 253 million in the US, Lupin said.

Read Also: Lupin gets USFDA nod to Tadalafil to treat pulmonary arterial hypertension

"It is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older," the company added.

Lupin is a 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 a position in the Anti-TB segment.

Read Also: Lupin gets 2 observations from USFDA for its Goa facility