Zydus gets approval from USFDA for Exemestane

Zydus gets approval from USFDA for Exemestane

Agency News

Mumbai, Oct 5 : Pharma major Zydus Cadila said it has received the final approval from the USFDA to market Exemestane Tablets, 25 mg.

It will be manufactured at the group's formulations manufacturing facility at SEZ, Ahmedabad, the company said in a filing with BSE. The estimated sale for Exemestane Tablets is USD68.6 million (Source: IMS Health, IMS National Sales Perspective Audit, MAT Angust 2018, extracted September 2018,).

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 benefited 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.UNI