Aurobindo receives FDA approval for clobazam oral suspension, 2.5 mg/mL

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EAST WINDSOR, N.J. – Aurobindo Pharma has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application clobazam oral suspension, 2.5m/mL. Aurobindo Pharma’s clobazam oral suspension, are an AB-rated generic equivalent to the reference listed drug (RLD), ONFI Oral Suspension, of Lundbeck Pharmaceuticals.

Clobazam oral suspension are indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.

Clobazam oral suspension has an estimated market size of US $3.6 Million for the twelve months ending January 2022, as per IQVIA.


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