Important note: Information in this article was accurate in 2009. The state of the art may have changed since the publication date.
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Food and Drug Administration - June 1, 2009
Richard Klein & Kimberly Struble
On May 29, 2009, FDA granted tentative approval for generic lamivudine/zidovudine tablets 150 mg/300 mg indicated for treatment for Human Immunodeficiency Virus (HIV) in patients with or without Acquired Immunodeficiency Syndrome (AIDS), made by Macleods Pharmaceuticals Limited, of Daman, India.
Tentative approval means that FDA has concluded that a drug product has met all of the required quality, safety and efficacy standards, but that it may not be marketed in the U.S. due to existing patents rights. However, tentative approval makes the product eligible to be considered for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR) program. Existing patent information is available in the FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
FDA conducts an on-site inspection of each manufacturing facility and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval of these applications to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application.
A list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan can be found on the FDA website.
The lamivudine/zidovudine fixed dose combination tablets are a version of the FDA approved Combivir tablets manufactured by GlaxoSmithKline.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
SOURCE: Food and Drug Administration (FDA).
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