FDA gives tentative approval to new generic AIDS drug

	Tweet

The Food and Drug Administration (FDA) today announced the tentative approval of generic abacavir sulfate tablets manufactured by Aurobindo Pharma LTD. of Hyderabad, India.

Abacavir sulfate tablets are the first generic version of the already approved Ziagen Tablets, an anti-HIV medication manufactured by GlaxoSmithKline.

This product will now be available for consideration for purchase under the President’s Emergency Plan for AIDS Relief.

"FDA’s action adds yet another anti-HIV product to those available for purchase under the President’s Plan and demonstrates our continuing commitment to ensuring that safe, effective, and quality manufactured medications are available for purchase under the President’s Plan,” said Murray M. Lumpkin, M.D., Deputy Commissioner for International and Special Programs.

The President’s Emergency Plan for AIDS Relief, which President Bush first announced in his 2003 State of the Union Address, is currently providing $15 billion to fight the HIV/AIDS pandemic over five years, with a special focus on 15 of the hardest hit countries. The President’s plan is designed to prevent seven million new HIV infections, treat at least two million HIV-infected people, and care for ten million HIV-affected individuals, AIDS orphans and vulnerable children. It targets three specific areas related to HIV/AIDS:

• Prevention of HIV transmission;
  
• Treatment of AIDS and associated conditions;
  
• Care, including palliative care for HIV infected-individuals, and care for orphans and vulnerable children.

Abacavir is one of the non-nucleoside reverse transcriptase inhibitors (NRTIs), a class of drugs that helps keep the AIDS virus from reproducing. It is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.

The agency’s tentative approval of this product means that Aurobindo’s product meets all of FDA’s manufacturing quality and clinical safety and efficacy standards. Although existing patents and/or exclusivity prevent its marketing in the United States, the product can be marketed abroad and used under the PEPFAR plan.

More information on HIV and AIDS is available online at FDA’s website:http://www.fda.gov/oashi/aids/hiv.html

RELATED STORIES:
FDA Advisory Panel Approves Home HIV Test Kit   FDA Approves New In-Home HIV Test   Home HIV test advances   Survey Reveals Support for Over-the Counter HIV Testing   F.D.A. Panel Weighs Preventive Use of H.I.V. Drug   Stem Cell Therapy Shows Promise in Fight Against HIV   Progress against HIV thwarted by patients’ unmet needs   California to test pill for HIV prevention   Mechanism of HIV spread has potential for future drug therapy   Seeking HIV treatment clues in the neem tree   HIV Prevention Pill’s Value Varies by Target   Using AIDS drugs to prevent infection: a bargain?

Comments

[ + Post Your Own ]

Now you're in the public comment zone. What follows is not Armenian Medical Network's stuff; it comes from other people and we don't vouch for it. A reminder: By using this Web site you agree to accept our Terms of Service. Click here to read the Rules of Engagement.

There are no comments for this entry yet. [ + Comment here + ]