FDA approves Glenmark’s generic Thorazine

The Food and Drug Administration has given its blessing to Glenmark chlorpromazine hydrochloride tablets in dosage strengths of 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg.

The generic of GlaxoSmithKline's Thorazine is indicated as an antipsychotic medication used to treat such psychotic disorders as schizophrenia, manic-depression and severe behavioral problems in children will soon be available.

Glenmark has been granted a competitive generic therapy designation for its generic product. As the first approved applicant for such competitive generic therapy, Glenmark is eligible for 180 days of CGT exclusivity upon commercial marketing.

Thorazine had a market value of approximately $108.6 million for the 12 months ended January 2021, according to IQVIA.