ROBINS REFORMULATING DIMETAPP TO ELIMINATE PHENYLEPHRINE HCI

ROBINS REFORMULATING DIMETAPP TO ELIMINATE PHENYLEPHRINE HCI from the decongestant/antihistamine products. NDA supplements filed by Robins call for the Dimetapp products, which include a controlled release tablet Extentabs, and a liquid Elixir, to contain only brompheniramine maleate and phenylpropanolamine HC1, a drug combination considered safe and effective by FDA's OTC drug review panel. The reformulation by Robins was noted by FDA in a Dec. 23 Federal Register notice revoking NDA approval of the original formulation containing phenylephrine HCl. While determining that the Dimetapp products "lack substantial evidence of effectiveness in their old formulations," FDA announced it "has reviewed all available evidence and concludes that (the products), as reformulated, are effective" as a decongestant/antihistamine combination. FDA said it "is prepared to approve abbreviated new drug applications for the formulations now regarded as effective and supplements to the previously approved new drug applications." The FDA decision on Dimetapp was issued as a Drug Efficacy Study Implementation (DESI) notice. In enacting the DESI program, FDA granted certain cough/cold/allergy oral prescription drugs an exemption permitting them to remain on the market beyond the time limit scheduled for market removal pending recommendations of the OTC review panel, which issued a proposed monograph on the cough/cold products in 1976, and feedback from the affected NDA holders. Since 1976 FDA had revoked the exemption for all products except Dimetapp. With the Dimetapp decision FDA announced that the exemption category "is effectively dissolved and no longer applies to any drug product."