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Tentative approval for generic Reyataz

Mylan has won tentative US approval for its generic version of Bristol Myers Squibb's Reyataz HIV drug under the President's Emergency Plan for AIDS Relief

Mylan's Matrix Laboratories division has won tentative approval from the US Food and Drug Administration for its generic version of Bristol Myers Squibb's (BMS) Reyataz HIV drug (atazanavir sulfate) under the President's Emergency Plan for AIDS Relief (PEPFAR), the US government's plan to fight HIV/AIDS in developing countries that was launched in 2003.

Tentative approval signifies that a generic product meets all of the FDA's manufacturing quality, safety and efficacy standards but cannot yet receive final marketing approval in the US because the branded drug's patent protection is still in effect. PEPFAR allows the purchase of any product that has either a full or tentative FDA approval in order to distribute the products in the developing countries hardest hit by the HIV/AIDS epidemic. 

PEPFAR was initially criticised for distributing only branded versions of drugs, but in late 2005 began to distribute cheaper generic drugs as well. 

Mylan said that it will sell its generic atazanavir in developing countries outside the US, making it the first generic version of the product widely available in those markets.

Atazanavir is a once-daily protease inhibitor (PI) that has a distinct resistance profile compared with other PIs and is used in combination with other medications to control HIV infection. It carries less risk of lipodystrophy and elevated cholesterol than other PIs.

The FDA approved the branded version of Reyatz in June 2003 in 150mg capsules and cleared a new 300mg formulation intended to be used as part of combination drug therapy in October 2006. Reyataz was one of BMS' top-three products in 2009, with sales of $1.4bn.

5th October 2010

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