New FDA Approvals
November 1, 2003 2 minutes read
These drugs recently received final approval from the U.S. Food and Drug Administration (FDA):
• New indication for eplerenone (Inspra) by Pfizer. The FDA has approved eplerenone (Inspra) tablets for improving the survival of congestive heart failure patients following an acute heart attack.
Eplerenone is the first member of the aldosterone receptor blocker class of drugs to receive approval for this indication. The use of eplerenone in the placebo-controlled clinical trial supporting its approval resulted in a significant (15%) reduction in the risk of death. The reduction in the risk of death and improved survival with eplerenone occurred in patients who were typically receiving other appropriate therapy.
The FDA first approved eplerenone in 2002 for the treatment of hypertension. The FDA reviewed the sponsor’s application for the new use of eplerenone on a priority basis, approving it within six months of receipt.
• New formulation of propoxyphene napsylate and acetaminophen (Darvocet A500) by aaiPharma. The FDA has approved propoxyphene napsylate and acetaminophen (Darvocet A500) for the treatment of mild-to-moderate pain. AaiPharma says the drug is the only propoxyphene napsylate/acetaminophen combination product currently FDA-approved that contains a lower (500 mg) dose of acetaminophen combined with 100 mg propoxy-phene napsylate, the same dose of propoxyphene napsylate found in Darvocet-N® 100.
• New indication for valganciclovir HCl tablets (Valcyte) by Hoffmann-La Roche. The FDA has approved valganciclovir HCl tablets (Valcyte) for the prevention of cytomegalovirus (CMV) disease in high-risk kidney, kidney-pancreas, and heart transplant patients, adding another indication to the drug’s original approval in March 2001 for the treatment of CMV retinitis in AIDS patients. Valganciclovir HCl tablets are not indicated for use in liver transplant patients.
These drugs recently received final approval from the U.S. Food and Drug Administration (FDA):You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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