Ivax wins FDA approval for albuterol sulfate

Drug Store News, Jan 17, 2000

The Food and Drug Administration has approved WAX Corp.'s ANDA for albuterol sulfate inhalation solution, 0.083% in 3 ml unitdose vials. Albuterol sulfate, used to treat asthma and other respiratory diseases, is the generic equivalent of Schering-Plough's Proventil inhalation solution. Ivax said the product has already been marketed in the United Kingdom, Europe and Canada.

Sales in the United States have begun recently through Ivax's Zenith Gold-line Pharmaceuticals subsidiary. The product, for use in nebulizers, is manufactured at Steripak Limited of Runcorn, England, an Ivax subsidiary.