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Approval of generic nevirapine formulations
  On May 22, 2012, FDA approved ten generic product applications (Abbreviated New Drug Applications/ANDAs) for nevirapine tablets USP, 200 mg from the following producers:

· Apotex Corporation

· Aurobindo Pharma Limited

· Cipla Limited

· Hetero Labs Limited

· Matrix Laboratories Limited

· Micro Labs Limited

· Mylan Pharmaceuticals, Inc.

· Prinston Pharmaceutical, Inc.

· ScieGen Pharmaceuticals, Inc

· Strides, Inc.

In addition, one generic approval was granted for an oral suspension formulation USP 50 mg/mL, made by Aurobindo Pharma Limited.

These products are generic versions of the Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI), Viramune, made by Boehringer Ingelheim.

Patent information for all approved drugs is available in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.

The approvals mean that these generic nevirapine formulations can be marketed in the United States.

A comprehensive list of the approved generic HIV therapeutic drug products is available on the FDA HIV web site.

Richard Klein Office of Special Health Issues Food and Drug Administration

Kimberly Struble Division of Antiviral Drug Products Food and Drug Administration

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