FDA gives tentative approval to Cipla combo pill for HIV
SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to a new drug for HIV made by an Indian company.
FDA records show that the agency gave tentative approval tablets and oral suspension that combine lamivudine, nevirapine and zidovudine in the 30-mg/50-mg/60-mg strength.
The drug doesn't currently carry a brand name, and all three active ingredients are available as generics; Apotex and Aurobindo market generic versions of lamivudine, a generic version of ViiV Healthcare's Epivir, while versions made by several other companies have tentative FDA approval.
A Cipla tablet that combines the three ingredients in the 150-mg, 200-mg and 300-mg strengths, respectively, received tentative approval from the FDA in 2007 and is marketed outside the United States as Duovir N.
Tentative approval means that a drug meets the FDA's requirements for approval, but the agency can't allow the manufacturer to launch because of the branded drug's patent or the market exclusivity period of another company making a generic version hasn't expired.