Zydus receives final approval from the USFDA for Five products within a week

Zydus receives final approval from the USFDA for Five products within a week

Zydus Cadila has received the final approval from the USFDA for Five products. This approval includes to market Abacavir and Lamivudine Tablets USP, 600 mg/300 mg (US RLD – EPZICOM), and Fondaparinux Sodium Injection USP, 2.5 mg/0.5 mL, 5 mg/0.4 mL 7.5 mg/0.6 mL and 10 mg/0.8 mL single-dose (US RLD – ARIXTRA). Abacavir and Lamivudine Tablets are used with other antiretroviral medicines to treat Human Immunodeficiency Virus-type 1 (HIV-1) infection. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. Fondaparinux Injection is used to treat blood clots in deep veins (deep vein thrombosis) and the lungs (pulmonary embolism). It can also be used to prevent blood clots in patients undergoing certain types of surgeries. It will be manufactured at a partner’s manufacturing site. The group now has more than 230 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus receives approval from USFDA for Arsenic Trioxide Injection

Zydus Cadila has received the final approval from the USFDA to market Arsenic Trioxide Injection, 10 mg/10 mL (1 mg/mL) single-dose vial (US RLD – TRISENOX®). It will be manufactured at Alidac Pharmaceuticals Ltd., the company’s wholly-owned subsidiary located at SEZ, Ahmedabad. Arsenic Trioxide is used to treat a type of leukemia (acute promyelocytic leukemia-APL) when other types of treatment (e.g., chemotherapy) have not worked well or no longer work.

Zydus receives final approval from the USFDA for Nystatin and Triamcinolone Acetonide Ointment USP

Zydus Cadila has received the final approval from the USFDA to market Nystatin and Triamcinolone Acetonide Ointment USP, (US RLD – Mycolog®-II Ointment), 100,000 units/gram and 1 mg/gram. It will be manufactured at the group’s Topical manufacturing facility at Ahmedabad. It is used to treat fungal skin infections. This product contains nystatin, an anti-fungal drug that works by stopping the growth of fungus. It also contains triamcinolone, an antiinflammatory corticosteroid that works by reducing swelling, itching, and redness.