USFDA gives nod for Granules’ generic BP drug


Drugmaker Granules has received US Food and Drug Administration approval for a generic version of Prazosin Hydrochloride Capsules, a drug indicated in the treatment of hypertension (high blood pressure).

Bioequivalent to the reference listed drug, Mini plus capsules 1mg, 2mg and 5mg of Pfizer Inc, the approved product would be available for the U.S market shortly, Granules India said on USFDA approving the ANDA of subsidiary Granules Pharmaceuticals Inc. (GPI).

The current annual U.S. market for Prazosin Hydrochloride 1mg, 2mg, 5mg strengths is approximately $54 million, the company said in a release citing IQVIA/IMS Health numbers.

GPI executive director Priyanka Chigurupati said the product “will surely be a valuable addition to our growing product portfolio in the U.S. market.” Granules now has 46 ANDA approvals from USFDA (44 final approvals and two tentative approvals).



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