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The US Food & Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) filed by Granules Pharmaceuticals Inc (GPI), a wholly-owned foreign subsidiary of Granules India, for Prazosin Hydrochloride Capsules.
It is bioequivalent to the reference listed drug product (RLD), Mini plus capsules of Pfizer Inc. The product would be available in the US market shortly.
“We are pleased to receive the approval for the product and it will surely be a valuable addition to our growing product portfolio in the US market,'' Priyanka Chigurupati, Executive Director, GPI said in a release issued here on Tuesday.
The current annual US market for Prazosin Hydrochloride is approximately $54 million, according to industry estimates. The drug is generally indicated in the treatment of high blood pressure.
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