FDA sees no safety issues with Pfizer HIV drug
October 6, 2009(AP) -- The Food and Drug Administration says an HIV drug from Pfizer appears safe for expanded use in patients who have not taken other drugs to combat the virus.
Selzentry is already approved as a secondary option for HIV patients who are not responding to other antiviral drugs. Now the company is asking the FDA to approve the drug as a first-choice treatment.
FDA scientists appeared to favor the new use in briefing documents posted online Tuesday.
One review says "no new safety signals were identified in association" with the drug.
On Thursday, the FDA will ask a panel of outside experts to vote on Selzentry's safety and effectiveness. The agency usually follows the group's advice, though it is not required to do so.
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