New Delhi: Zydus Cadila has received approval from the US health regulator to market Doxazosin tablets, used for the treatment of high blood pressure and urinary retention associated with enlargement of the prostate gland.
The company “has received the final approval from the United States Food and Drug Administration (USFDA) to market Doxazosin tablets USP, 1 mg, 2 mg, 4 mg, and 8 mg”, Zydus Cadila said in a statement.
The drug is used to treat high blood pressure and urinary retention associated with benign prostatic hyperplasia, it added.
The company has also received the tentative approval from the USFDA to market Lurasidone Hydrochloride Tablets in the strengths of 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg, Zydus Cadila said.
The drug is used in the treatment of schizophrenia, it added.
Both Doxazosin tablets and Lurasidone Hydrochloride tablets will be produced at the group’s formulations manufacturing facility at the Pharma SEZ in Ahmedabad, Zydus Cadila said.
The group now has more than 120 approvals and has so far filed over 300 abbreviated new drug applications (ANDAs), it added.