Zydus Cadila receives four consecutive ANDA approvals from USFDA

18 Jul 2018 Evaluate

Zydus Cadila has received four consecutive final approvals from the US Food and Drug Administration (USFDA) to market Olanzapine Tablets USP, Glipizide Extended-Release Tablets, Voriconazole for Injection and Fluocinonide Topical Solution USP.

Olanzapine Tablets USP (US RLD -Zyprexa Tablets) approved in strengths of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg are used to treat certain mental/mood conditions (such as schizophrenia, bipolar disorder). Glipizide Extended-Release Tablets (US RLD - Glucotrol XL), 2.5 mg, 5 mg, and 10 mg, are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Voriconazole for Injection (US RLD - Vfend for Injection), 200 mg single-dose vial is indicated for use in patients, 12 years of age and older in the treatment of invasive aspergillosis, candidemia in non-neutropenic patients, esophageal candidiasis and serious fungal infections. These three products will be manufactured at the group’s manufacturing facility at Moraiya, Ahmedabad.

Fluocinonide Topical Solution USP, 0.05% (US RLD - Lidex Topical Solution) is used to treat a variety of skin conditions and reduces the swelling, itching, and redness that can occur in these types of conditions. It will be manufactured at the group’s Topical manufacturing facility at Ahmedabad. In line with this, the group now has 208 approvals and has so far filed over 330 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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