Zydus receives final approval from the USFDA for Exemestane tablets

Zydus Cadila has received the final approval from the USFDA to market Exemestane tablets (US RLD – AROMASIN tablets), 25 mg. They will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. Exemestane belongs to the group of medicines called aromatase inhibitor. It is used in women after menopause for the treatment of early breast cancer (cancer that has not spread outside the breast) in women who have cancer that needs the female hormone estrogen to grow, have had other treatments for breast cancer for 2-3 years and are switching to Exemestane to complete 5 years in a row of hormonal therapy.

It is also used in the treatment of advanced breast cancer (cancer that has spread) after treatment with other therapies, where it has not benefitted the patient or is no longer effective. The group now has 220 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04.