AEGiS-FDA: Tentaive approval of generic nevirapine tablets, 200 mg

Important note: Information in this article was accurate in 2009. The state of the art may have changed since the publication date.

Tentaive approval of generic nevirapine tablets, 200 mg

Food and Drug Administration - April 1, 2009
Richard Klein & Kimberly Struble

On March 31, 2009, the Food and Drug Administration granted tentative approval for a generic formulation of nevirapine tablets, USP, 200 mg indicated for combination antiretroviral treatment of HIV-1 infection. Manufactured by MacLeods Pharmaceuticals Limited of Daman, India, this tentatively approved formulation is a generic version of the Nonnucleoside Reverse Transcriptase Inhibitor, (NNRTI), Viramune tablets, USP, 200 mg, manufactured by Boehringer Ingelheim.

"Tentative approval" means that FDA has concluded that a drug product meets all required quality, safety and efficacy standards, but is not presently eligible for final approval or marketing in the U.S. because of existing patents and/or exclusivity rights. However, tentative approval does make the product eligible for purchase outside the United States under the President's Emergency Plan for AIDS Relief (PEPFAR; www.pepfar.gov).

Effective patent dates can be found in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations <http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=020636&TABLE1=OB_Rx>, also known as the Orange Book.

The application was reviewed under expedited review provisions for PEPFAR.

Richard Klein

Office of Special Health Issues

Food and Drug Administration

Kimberly Struble

Division of Antiviral Drug Products

Food and Drug Administration

090401
FD090401

SOURCE: Food and Drug Administration (FDA).

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