Lupin gets USFDA approval for Ziprasidone Hydrochloride capsules

05 Mar 2012 Evaluate

Lupin has received final approval for its Ziprasidone Hydrochloride capsules, 20mg, 40mg, 60mg and 80mg strengths from the United States Food and Drugs Administration (USFDA). Lupin’s Ziprasidone Hydrochloride capsules are AB rated generic equivalent of Pfizer Inc.’s Geodon capsules. Lupin has already commenced shipping the product.

Geodon capsules are 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 applicant to file an ANDA for Geodon Ziprasidone Hydrochloride capsules, 20mg, 40mg, 60mg and 80mg strengths and is entitled to shared exclusivity.

Lupin has a vibrant presence in the Indian pharmaceuticals market and has over the past several years made major strides in expanding its therapy portfolio. The company has a robust promotion and distribution setup along with a strong presence in various therapeutic areas, including the fast growing diabetes market.

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