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FDA advisory committee to consider OTC NDA for asthma-relieving Primatene HFA
SILVER SPRING, Md. — The Nonprescription Drugs Advisory Committee on Thursday announced it would meet February 25 to discuss data submitted by Armstrong Pharmaceuticals in support of a new drug application for the over-the-counter marketing of Primatene HFA, an epinephrine inhalation aerosol 125 microgram (mcg)/actuation, as a temporary reliever of mild symptoms of intermittent asthma for consumers 12 years of age and older.
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FDA approves liquid form of Merck HIV drug Isentress for infants, small children
WHITEHOUSE STATION, N.J. — The Food and Drug Administraiton has approved a liquid formulation of an HIV drug made by Merck, the company said.
Merck announced the approval of Isentress (raltegravir) for oral suspension, aimed at small children with HIV. The drug may be used by patients as young as four weeks, and the full line of formulations of Isentress now includes the orlal suspension, as well as chewable tablets and film--coated tablets. The company plans to launch the oral suspension in the third quarter of this year.