Breckenridge awarded US FDA's final approval for Exemestane Tablets (Aromasin) ANDA
28 February 2019 -

Pharmaceutical company Breckenridge Pharmaceutical Inc disclosed on Wednesday the receipt of the US Food and Drug Administration's final approval for its Abbreviated New Drug Application for Exemestane Tablets in 25mg.

The company added that the Exemestane Tablets in 25mg is the generic version of Pfizer's Aromasin Tablets.

In conjunction, Breckenridge's Exemestane Tablets product was developed in collaboration with Medikl Ltd and MSN Laboratories Private Ltd. MSN will manufacture and supply the product from its facilities in Hyderabad, India. Additional announcements will be made prior to product launch.

For the 12 months ending 31 December 2018, Exemestane Tablets generated annual sales of USD65m, according to industry sales data.

Exemestane Tablets is reportedly used to treat certain types of breast cancer (such as hormone-receptor-positive breast cancer) in women after menopause.