Schering Proventil to be added as reference list drug for generic albuterol MDIs.
Executive Summary
GENERIC ALBUTEROL MDI PRODUCTS MAY SEEK EQUIVALENCE TO SCHERING's PROVENTIL, FDA ruled in a Sept. 9 response to a Lachman Consultant Services petition to include Proventil as a reference for generic albuterol metered-dose inhalers ("The Pink Sheet" June 17, T&G-17). In granting the petition, submitted by former Office of Generic Drugs Program Support Staff Chief Robert Pollock, the agency states that it "will designate Proventil, in addition to [Glaxo Wellcome's] Ventolin, as a reference listed drug" in the "Orange Book."
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