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Executive Summary

The renaissance at FDA's Office of Generic Drugs is evident in a big surge of March ANDA approvals: 28 abbreviated new drug applications were approved by the agency last month. The March approval total is the highest single-month tally since May 1989. In December, the generic office approved 23 products; the monthly approval rate had been hovering at close to 20 ANDAs for the five previous months. One of the most significant ANDA decisions in March from a commercial standpoint was the March 16 clearance for Mylan for four dosages of diltiazem (marketed currently by Marion Merrell Dow as Cardizem). The approval is the first for a generic version of the number two calcium channel blocker in the U.S. Mylan cannot market the product until the brand's exclusivity protection expires on Nov. 5, but the approval may have flushed out a pending generic introduction by Rugby, which has marketing rights to a generic version through an MMD affiliate (see previous story). Another of the important "firsts" in March was Lemmon's albuterol sulfate syrup 2 mg/5 ml (Glaxo's Ventolin syrup and Schering's Proventil syrup). Lemmon's albuterol syrup is a different formulation than Ventolin and therefore does not infringe the innovator's formulation patent, which is valid until Feb. 12, 2002. Lemmon plans to launch the beta-adrenergic bronchodilator by the end of April at a 30%-35% discount to the brandname products. According to the 1992 "Red Book," Proventil syrup has an average wholesale price $29.14 for 480 ml of the 2 mg/5 ml product. Lemmon estimates that the market for albuterol syrups is about $40 mil. Danbury Pharmacal received a first generic approval during the month, for the oral solid dosage form of the antidepressant nortriptyline HCl on March 30. The drug will be "AB"-rated to Sandoz' Pamelor, which Danbury parent Schein Pharmaceutical estimates had sales approaching $200 mil. last year. Under a January 1991 exclusive licensing agreement with Sandoz, Danbury will market nortriptyline prior to the patent's expiration on Nov. 25. Schein said it will begin shipping the generic nortriptyline on July 5. Merck originally owned the patent to the drug but licensed nortriptyline to Lilly, which markets the drug as Aventyl. Sandoz now owns the patent. Danbury Pharmacal received the most ANDA approvals (25) in 1991. When those ANDAs are added to the 11 approvals received last year by Danbury's sister firm Steris Labs, the parent company Schein Pharmaceutical has a total of 36 generic approvals, or one- fifth of all the ANDA approvals last year. During March, Mylan gained the second tentative approval for a generic version of Warner-Lambert's cholesterol-lowering drug Lopid (gemfibrozil). Purepac received tentative approval for the first generic copy of Lopid last October ("The Pink Sheet" Oct. 14, T&G-10). The products were tentatively approved because Warner-Lambert has a patent on Lopid that does not expire until January 1993. Both ANDAs are for 300 mg, a dose which Warner- Lambert discontinued marketing in 1991. SmithKline Beecham received ANDA approvals for a new formulation of its broad-spectrum antibiotic ceftazidime for injection (Pentacef). SmithKline developed an L-arginine formulation to eliminate a bubbling problem associated with preparing injectable ceftazidime products. Glaxo's ceftazidime, Ceptaz, which also was reformulated to handle the bubbling problem, was approved through the NDA route in September 1990.

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