East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Ziprasidone HCl Capsules, 20 mg, 40 mg, 60 mg and 80 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Ziprasidone HCl Capsules, 20 mg, 40 mg, 60 mg and 80 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD), Geodon® Capsules of Pfizer, Inc.
Ziprasidone HCl Capsules, 20 mg, 40 mg, 60 mg and 80 mg is indicated for the treatment of Schizophrenia.
The product has an estimated market size of $117M for the twelve months ending November 2016 according to IMS*.
Ziprasidone HCl Capsules, 20 mg, 40 mg, 60 mg and 80 mg represents the latest addition to Aurobindo’s broad line of vertically integrated generic pharmaceuticals. Aurobindo’s product portfolio consists of 254 final approvals, including 39 tentative approvals, and 16 approved products from Aurolife. There are 97 additional products on file with U.S. FDA.
* IMS National Sales Perspectives: Retail and Non-Retail MAT November 2016