Zydus receives final approval from the USFDA for 3 products

Zydus Cadila has received the final approval from the USFDA to market Candesartan Cilexetil and Hydrochlorothiazide Tablets USP in the strengths of 16 mg/12.5 mg, 32 mg/12.5 mg and 32 mg/25 mg. The drug combines an angiotensin II receptor (type AT1) antagonist and a diuretic, hydrochlorothiazide and is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.

Zydus Cadila has received the final approval from the USFDA to market Topiramate Extended-Release Capsules in the strengths of 25 mg, 50 mg, and 100 mg. The drug is indicated for the treatment of seizures and migraine headaches. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.

Zydus Pharmaceuticals (USA) Inc., a wholly owned subsidiary of Cadila Healthcare Limited, has received the final approval from the USFDA to market Minocycline Hydrochloride Extended-Release Tablets in strengths of 45 mg, 80 mg, 90 mg, 105 mg, and 135 mg. Zydus also received the tentative approval for Minocycline Hydrochloride Extended-Release Tablets, 55 mg, 65 mg, and 115 mg. Minocycline Hydrochloride Extended-Release Tablets are a tetracycline-class drug, indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. It will be produced at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.