Zydus Receives Four Consecutive ANDA Approvals from USFDA

Zydus Cadila announced that it has received four consecutive final approvals from the 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). It may also be used in combination with other medications to treat depression. 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 nonneutropenic 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 percent (US RLD – Lidex Topical Solution) is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies and rash) 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. – Medical Buyer Bureau