Granules India today said it has received approval from the US health regulator for its generic Prazosin Hydrochloride capsules used for the treatment of high blood pressure.
The US Food and Drug Administration (FDA) granted approval to the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI) — a wholly-owned foreign subsidiary of the company — for Prazosin Hydrochloride capsules, of strengths 1mg, 2mg and 5mg, Granules India said in a statement.
These capsules are bioequivalent to the reference listed drug product, Mini plus capsules 1mg, 2mg and 5mg of Pfizer Inc, it said, adding the product would be available for the US market shortly.
Citing IQVIA/IMS Health data, the company said the current annual US market for Prazosin Hydrochloride 1mg, 2mg, 5mg strengths is approximately $54 million.
Edits by EP News Bureau