FDA approval of three generic stavudine formulations to destroy faces

[Guest guest]

This is an F*ing tragedy that people in the developing world

will be paying for with the stigmatization that comes from wearing the mark of

AIDS on their wasted faces…. I read the latest justification from BMS…that

lipoatrophy does not strike ‘people of color’ like it does white folks, so it’s

ok to sell Stavudine in Africa. I so wish somebody had at least attempted to

sue the bastards.—a

From: U.S. Food &

Drug Administration (FDA) [mailto:fda@...]

Sent: Tuesday, December 30, 2008 8:22 AM

al@...

Subject: HIV/AIDS Update - FDA approval of three generic stavudine

formulations

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On December

29, 2008 FDA granted approval for three generic fomulations of stavudine.

Stavudine is a Nucleoside Reverse Transcriptase Inhibitors (NRTI), which helps

keep HIV, the virus that causes AIDS, from reproducing. It is intended to be

used in combination with other anti-retroviral agents for the treatment of

HIV-1 infection.

The approved generic formulations are stavudine capsules (15 mg, 20 mg, 30 mg

and 40 mg), and Stavudine for Oral Solution (1 mg/mL), both manufactured by

Aurobindo Pharma; and stavudine capsules (15 mg, 20 mg, 30 mg and 40 mg)

manufactured by Hetero Drugs Limited, both of Hyberdad, India.

FDA has determined that Aurobindo's stavudine for oral solution and stavudine

capsules are bioequivalent and, therefore, therapeutically equivalent to Zerit

oral solution 1mg/mL and 15 mg, 20 mg, 30 mg, and 40 mg capsules, respectively,

made by Bristol-Myers Squibb.

Similarly, Hetero's stavudine capsules were determined to be bioequivalent, and

thus therapeutically equivalent to Zerit Capsules, 15 mg, 20 mg, 30 mg, and 40

mg.

The patent and pediatric exclusivity protections associated with the originator

product have expired, so these generic formulations are approved for marketing

in the United States.

Klein

Office of Special Health Issues

Food and Drug Administration

Struble

Division of Antiviral Drug Products

Food and Drug Administration

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