Lupin gets USFDA nod for generic schizophrenia capsules
New Delhi: Drug firm Lupin today said it has received approval from the US health regulator for its generic Ziprasidone Hydrochloride capsules, used for treating mental
disorders in the American market.
The company`s subsidiary Lupin Pharmaceuticals Inc has received final approval for its Ziprasidone Hydrochloride capsules in the strengths of 20 mg, 40 mg, 60 mg and 80 mg
from the United States Food and Drug Administration (USFDA), Lupin said in a statement.
The capsules are generic equivalent of Pfizer Inc`s Geodon capsules in the same strengths and the firm has already commenced shipping them, it added.
"Pfizer`s Geodon capsules had sales of USD 1.35 billion as per IMS Health, December 2011, Lupin said.
Geodon capsules are indicated for Schizophrenia. The company said it is one of the first applicants to file an abbreviated new drug application (ANDA) for Geodon Ziprasidone Hydrochloride Capsules in the strengths of 20 mg, 40 mg, 60 mg and 80 mg strengths and is entitled to shared exclusivity.
Lupin Ltd scrips were trading at Rs 491 per share during the mid-day trade on the BSE, down 0.46 per cent from its previous close.