Go-Ahead For Generic Albuterol In USA

At the end of 1995, the US Food and Drug Administration finally gave its approval for a generic version of the beta agonist bronchodilator albuterol, the active ingredient in Glaxo Wellcome's Ventolin and Schering-Plough's Proventil brands. Ivax launched the drug within 24 hours of the approval through its Zenith Goldline subsidiary.

The approval in the USA has come after repeated attempts by the brand name companies to block clearance of a generic product, although Ivax has been selling albuterol inhalers in 30 countries worldwide for some time. Overall, it has taken seven years to get the generic onto the US market, largely because of the stringent bioequivalence criteria laid down by the FDA. The difficulty lay in the highly variable delivery of compound to the lungs using metered dose inhalers (including those used by brand name companies).

Both S-P and GW mounted challenges to Ivax' bioequivalence data in the past, but the latest round of petitions came from 3M, which has a non-CFC-propelled albuterol MDI pending at the FDA, according to the Pink Sheet. Nevertheless, political lobbying by the likes of Rep Henry Waxman, and thorough FDA testing of the product's bioequivalence, allowed the generic to pass through.