Pharma major Lupin Ltd. has received final approval for its ziprasidone hydrochloride capsules, 20mg, 40mg, 60mg and 80 mg strengths from the US Food and Drug Administration (FDA).

Lupin's ziprasidone hydrochloride capsules are the AB-rated generic equivalent of Pfizer Inc.'s Geodon capsules. Lupin has already commenced shipping product.

Geodon capsules are an atypical antipsychotic and are indicated for schizophernia. Pfizer's Geodon capsules had sales of US$ 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, 40mg, 60mg 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 very 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.”

Lupin is an innovation led transnational pharmaceutical company producing a wide range of quality, affordable generic and branded formulations and APIs.