Dayton, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Hydromorphone HCl Tablets, 2 mg, 4 mg, and 8 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limitedís Hydromorphone HCl Tablets, to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD), DilaudidÆ Tablets, 2 mg, 4 mg, and 8 mg of Purdue Pharma L.P.
Hydromorphone HCl Tablets, 2 mg, 4 mg, and 8 mg, is used to help relieve moderate to severe acute pain in patients where the use of an opioid is appropriate.
The approved Hydromorphone HCl product has an estimated market size of $49.3M for the twelve months ending April 2016 according to IMS*.
Hydromorphone HCl Tablets, 2 mg, 4 mg, and 8 mg, represents the latest addition to Aurobindoís broad line of generic pharmaceuticals. This is the 12th ANDA to be approved out of the Aurolife formulation facility in New Jersey. Aurobindoís product portfolio consists of 222 final approvals, including 36 tentative approvals and 12 from Aurolife Pharma LLC. There are 111 additional products on file with U.S. FDA.
* IMS National Sales Perspectives: Retail and Non-Retail MAT April 2016