Zydus Cadila has received approvals from the United States Food and Drug Administration (USFDA) for Olanzapine tablets, Glipizide extended-release tablets, Voriconazole for injection and Fluocinonide topical solution.
Zydus Cadila has received the final approval from the USFDA to market Piroxicam Capsules USP (US RLD - Feldene Capsules) in strengths of 10 mg and 20 mg. It is a non-steroidal anti-inflammatory drug indicated for symptomatic treatment of osteoarthritis and rheumatoid arthritis. It will be manufactured at the group’s manufacturing facility at SEZ, Ahmedabad. In line with this, the group now has 209 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04.
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% (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.
Zydus Cadila has received the final approval from the USFDA to market Clindamycin Phosphate Topical Solution USP (Cleocin T), 1%. Clindamycin is an antibiotic which works by stopping the growth of bacteria. It is used to treat acne and helps to decrease the number of acne lesions. It will be manufactured at group’s Topical manufacturing facility at Ahmedabad. In line with this, the group now has 204 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04.
Lupin received tentative approval for its Tadalafil Tablets
Pharma major Lupin announced that it has received tentative approval for its Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg from the United States Food and Drug Administration (FDA) to market a generic version of Eli Lilly and Company’s Cialis® Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg.
Lupin’s Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg is the generic version of Eli Lilly and Company’s Cialis® Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg. It is indicated for the treatment of:
Erectile dysfunction
The signs and symptoms of benign prostatic hyperplasia
Erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia
Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg had annual sales of approximately USD 1949.2 million in the US (IQVIA MAT April 2018).