FDA GRANTS TENTATIVE APPROVAL TO CIPLA'S TRIPLE HIV DRUG

The FDA has granted tentative approval to a generic fixed-dose, three-drug tablet for use as a complete antiviral treatment for HIV infection in adults. The tablet contains lamivudine, zidovudine and nevirapine, the active ingredients in the widely used antiretroviral drugs Epivir, Retrovir and Viramune. The new combination tablet is manufactured by Cipla.

The recommended regimen for the tablet is one pill twice a day following an initial two-week treatment with the three components taken individually. Each ingredient is currently approved to treat HIV-1 in combination with other antiretroviral agents. The safety and effectiveness of the combination in lowering the viral load and increasing the CD4+ cell has been demonstrated in studies of the individual ingredients being used together for treatment.

The labeling of the combination drug includes a medication guide and a boxed warning that the drug's use can cause liver failure, severe rash and lactic acidosis.

Because the drug has received tentative approval -- though it may not yet be marketed in the U.S. because of existing patents and/or exclusivity rights -- it is eligible for purchase under the President's Emergency Plan for AIDS Releif.

Zoloft (sertraline hydrochloride) had total annual sales of approximately $2.9 billion, according to IMS data for the 12 months ending in December 2006. The drug indicated for the treatment of major depressive disorder, obsessive-compulsive disorder and panic disorder.

Teva Pharmaceutical Industries was the first company to win approval for generic Zoloft, and therefore the company enjoyed 180 days of marketing exclusivity, which ended this week. The company filed multiple infringement lawsuits against the competing generic firms relating to patents on the crystalline forms of sertraline hydrochloride and how it is manufactured.