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Zydus Cadila gets final approval from USFDA for Exemesfane Tablets

Zydus Cadila has received the final approval from the US Food and Drug Administration (USFDA)  to market Exemestane Tablets, (US RLD – AROMASIN Tablets), 25 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. The estimated sale for Exemestane Tablets is $68.6 million.

Exemestane belongs to the group of medicines called ‘aromatase inhibitor’. It is used in women after menopause for the treatment of early breast cancer 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.

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.

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