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These drugs recently received final approval from the U.S. Food and Drug Administration (FDA).

Drug Criteria & Outcomes: New FDA approvals

May 1, 2003

Drug Criteria & Outcomes: New FDA approvals

These drugs recently received final approval from the U.S. Food and Drug Administration (FDA):

• New indication for Carvedilol (Coreg) by GlaxoSmithKline. The FDA has approved carvedilol (Coreg) for patients who have had a myocardial infarction and who have left ventricular dysfunction. Carvedilol is the only beta-blocking agent approved to reduce the risk of death in mild, moderate, and severe heart failure. It is now the only beta-blocking agent with an approved indication to reduce the risk of death among patients who have had a recent heart attack and have impaired cardiac function, whether or not they have symptoms of heart failure. Carvedilol also is indicated for essential hypertension.

• Reactive Skin Decontamination Lotion (RSDL) by O’Dell Engineering Ltd./E-Z-EM Canada. The FDA has cleared for use by the U.S. military a liquid decontamination lotion intended to remove or neutralize chemical warfare agents and T-2 fungal toxin from the skin. The lotion, called Reactive Skin Decontamination Lotion (RSDL), must be applied to exposed skin as soon as possible after exposure to a chemical agent.

The lotion is impregnated in a sponge pad packaged as a single unit in a heat-sealed foil pouch. When exposed to chemical warfare agents, the user wipes the exposed skin with the lotion. The lotion removes the agents or the T-2 toxin and also reacts with the chemical agents, rapidly neutralizing them so they are non-toxic.

• New indication for valacyclovir HCl (Valtrex) by GlaxoSmithKline. The FDA has approved a supplemental new drug application for valacyclovir HCl (Valtrex) caplets for the suppression of recurrent genital herpes in HIV-infected people.

Valacyclovir HCl is the first and only antiviral approved in the United States for suppression of recurrent genital herpes outbreaks in HIV-infected people. The drug also is indicated for initial and recurrent treatment and for suppression of genital herpes outbreaks in immunocompetent people.