FDA Approves Generic Albuterol Metered Dose Inhaler

December 29, 1995

The Food and Drug Administration today approved the first generic version of albuterol metered dose inhaler (MDI) based on newly developed methods to assess bioequivalence. The Albuterol MDI -- which is used to prevent and relieve bronchospasm in patients with asthma -- was found to be equivalent to the brand name product, Ventolin MDI.

The agency determined that the generic version is bioequivalent to the brand name product based upon a series of laboratory analyses and in vivo tests in humans. The generic version is, therefore, considered as safe and effective as the brand name product.

One set of laboratory tests, which is routinely used for measuring in vitro performance of aerosol products, determined the equivalence or similarity of the generic and brand name products for the delivered amount of albuterol, the particle size, and the shape of the aerosol cloud produced by both products.

The decisive assay of bioequivalence measured the product performance in asthmatic patients. This in vivo bioequivalence test used histamine as a challenge agent in what is termed a bronchoprovocation study. The equivalence of the pharmacological action of albuterol MDIs was established by comparing the generic version and the brand name product's capacity to protect the airways from constriction induced by histamine.

The bioequivalence of the generic albuterol MDI and Ventolin MDI was also confirmed by comparing the cardiovascular and metabolic effects of these products in healthy people at exposure levels substantially exceeding the recommended therapeutic doses.

The new generic product is produced by IVAX Corp. of Miami.
The brand name product, Ventolin MDI, is manufactured by Allen & Hanburys, a division of Glaxo Inc.

By Don McLearn/Susan Cruzan