May 30, FDA authorized pre-approval distribution of dideoxycytidine (ddC) under a treatment IND protocol for the treatment of patients with AIDS or advanced AIDS Related Complex who cannot be. Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. Drug Review Package. Combivir (Lamivudine/Zidovudine) Tablets Company: Glaxo Wellcome Inc. Application No.: 020857s008 Lamivudine (2′,3′-dideoxy-3. -a-day dosed medication. The fifth antiretroviral drug on the market, it was the last NRTI for three years while the approval process switched to protease inhibitors. According to the manufacturer’s 2004 annual report, its patent will expire in the United States in 2010 and in Europe in 2011. On September 2014, Dr. Gorbee Logan, a Liberian physician. Several FDA-approved drug labels may be available for Combivir. AIDSinfo provides the following drug label solely as an example of the labels available for Combivir. Title: 20-857S008 Combivir Approval Created Date: 2:13:52 PM Combivir, a combination of 2 nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection. Compare Combivir vs. Truvada, which is better for uses like: AIDS. Compare head-to-head ratings, side effects, warnings, dosages, interactions and patient reviews. Patients rated Truvada 3.7/5 over Combivir 3.6/5 in overall satisfaction. Drugs Used in the Treatment of HIV Infection. FDA-approved medicines used in the treatment of HIV can be found at Drugs@FDA or DailyMed. This list may not be comprehensive and it was last updated. The Food and Drug Administration today announced the approval of stavudine, or d4T -- the fourth drug approved for the treatment of AIDS and HIV infection.