US ANDAs filed for generic Beyaz, Isentress and Epivir

12 January 2012

The US Food and Drug Administration says that Abbreviated New Drug Applications have been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification for approval of generic versions of:

German drugmaker Bayer’s (BAY: DE) oral contraceptive Beyaz (drospirenone and ethinyl estradiol and levomefolate); GlaxoSmithKline’s (LSE: GSK) HIV/AIDS drug Epivir (lamivudine) and Merck & Co’s (NYSE: MRK) Isentress (raltegravir), also for the treatment of HIV patients.

The FDA said it will not disclose the identity of the applicant but added that this information will be updated twice a month and will be as current as the last update. At this time, no generic drugmaker has admitted filing an ANDA for any of these products.

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