Zydus gets USFDA’s nods for Doxycycline Hyclate Delayed-Release Tablets, Febuxostat Tablets

24 Dec 2018 Evaluate

Zydus Cadila has received the final approval from the USFDA to market Doxycycline Hyclate Delayed-Release Tablets USP (US RLD - Doryx) in the strengths of 75 mg, 100 mg and 150 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. This medication is used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

The group also received a tentative approval for Febuxostat Tablets (US RLD- Uloric), 40 mg and 80 mg. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. It is used to treat hyperuricemia (constantly high levels of uric acid) in adults who have gout. It helps in decreasing symptoms of gout which include pain, swelling, redness, heat, soreness, and stiffness in certain joints.

The group now has 241 approvals and has so far filed over 340 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.

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