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The first generic HIV/AIDS drug in capsule form for the U.S. market has been approved by the Food and Drug Administration. The same drug, zidovudine, already had approval in tablet and oral dosage forms.
The approval of the capsule form of the drug, made by Aurobindo Pharma in India, follows the expiration of GlaxoSmithKline's patent on Retrovir, its brand name form of zidovudine, the FDA said.
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"This is a significant generic approval," Dr. Andrew C. von Eschenbach, acting commissioner of the FDA, said in a prepared statement.
"Retrovir, which was initially approved in March, 1987, was the first of a group of breakthrough medications that have transformed what was then a disease with a very dismal prognosis into one with a much more hopeful prognosis. Approval of this additional dosage form of zidovudine should help reduce the cost of this therapy for American patients," von Eschenbach said.
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