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.