D. M. GRAHAM LABS RECEIVED 10 ANDA APPROVALS IN 1985

Executive Summary

D. M. GRAHAM LABS RECEIVED 10 ANDA APPROVALS IN 1985, the generic mfr. told "The Pink Sheet" in a recent letter. Eight of the approvals were for acetaminophen/butalbital combos, while two covered acetaminophen/hydrocodone products. In addition, the company said that there were eight ANDAs issued in 1985 "for our products in the names of our customers and for which we provided the bulk of the submission." This group includes three approvals for Fisons, two each for Gilbert Labs and Carnrick Labs and one for Mayrand. "Five ANDAs have been issued for our products in the names of our customers but these, by agreement, cannot be disclosed," the letter stated. Calling 1985 "a record year for approvals for D. M. Graham Labs," President Dean Graham, PhD, said that the results are indicative of "how effectively the FDA is currently processing their backlog." The exec noted that in addition to the ANDA approvals, the company received four NDAs during the year. Graham Labs has also apparently improved its standing with FDA inspectors in recent years. An establishment inspection report dated 1982 noted that the firm had "a history of manufacturing and shipping new drugs without approved NDAs or ANDAs and . . . of general manufacturing procedures problems." Reportedly, the company has not received an FDA reg letter since July 1982, however.