Our News Bureau – Mumbai
Lupin has received final approval for its Ziprasidone Hydrochloride Capsules, 20 mg, 40 mg, 60 mg and 80 mg strengths from the US Food and Drug Administration (FDA). Lupin’s ziprasidone h ydrochloride capsules are the AB rated generic equivalent of Pfizer’s Geodon capsules. Lupin has already commenced shipping product.
Geodon capsules are an a typical antipsychotic and are indicated for Schizophrenia. Pfizer’s Geodon capsules had sales of $1.35 billion as per IMS Health, December 2011. Lupin was one of the first applicants to file an ANDA for Geodon Ziprasidone Hydrochloride Capsules, 20 mg, 40 mg, 60 mg and 80 mg strengths and is entitled to shared exclusivity.
Commenting on the approval, Nilesh Gupta, Group President and Executive Director, Lupin said, “We are happy to receive this approval. Patients can be assured that they are receiving the same high quality product they have been accustomed to at a more affordable price.”