Boehringer Ingelheim drug approved in generic form

Boehringer Ingelheim’s Viramune brand has been approved in a generic form manufactured by Chinese firm Zhejiang Huahai Pharmaceutical, the Food and Drug Administration (FDA) has announced.

Existing exclusivity rights owed to Boehringer Ingelheim mean the generic nevirapine tablets may not yet be marketed.

However, being granted tentative approval means the treatment may be purchased via the President’s Emergency Plan for Aids Relief (Pepfar) programme.

This five-year scheme provides funding for global initiatives aimed at tackling the disease and is the largest support system for Aids in the world, according to the US government.

Boehringer Ingelheim maintains patents for the brand until May 22nd, 2012, while the FDA states that there is no end to the firm’s exclusivity rights.

The administration adds that it “conducts an on-site inspection of each manufacturing facility and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval”.