Zydus receives final approval from the USFDA for Abacavir & Lamivudine Tablets and Fondaparinux Sodium Injection

Cadila HealthcareZydus Cadila has received the final approval from the USFDA 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.

About Zydus Cadila

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. The group employs nearly 23,000 people worldwide and is dedicated to creating healthier communities globally. Zydus aspires to be a research-based pharmaceutical company by 2020.