PAR CLEARS MOST ANDAs IN 1987 WITH 32 APPROVALS; LYPHOMED AND QUAD LEAD INDUSTRY IN APPROVALS FOR DIFFERENT DRUGS; ABBOHAS 31 ANDAs

Executive Summary

Par was the most productive company in getting ANDAs cleared by FDA in 1987, with 32 approvals during the year. The bulk of Par's approvals (29) were for generic versions of post-1962 approved drugs. A number of the firm's approvals, which were all for solid oral dosage forms, covered different strengths of the same chemical entity. For example, Par received six approvals for different strengths of doxepin HC1 and three approvals for different combinations of clonidine with chlorthalidone. In total, Par's 32 approvals covered 13 different drug entities, 11 of which were versions of post-1962 drugs MOST ACTIVE FIRMS IN 1987 ANDA APPROVALS The following chart was compiled by "The Pink Sheet" from FDA's monthly listings of new drug approvals during the year. ANDA approvals are broken out into approvals for antibiotics, pre-1962 drugs and post-1962 drugs. The number of ANDA approvals are followed in parentheses by the number of different chemical entities the applications covered. Abbott, with 31 approvals for injectable drugs, was the second most active firm during the year. The company's approvals, also primarily for post-1962 drugs, covered 11 different drug entities. In terms of separate drug entities, LyphoMed obtained the most approvals, with 19 different chemical entities cleared during the year. The generic injectable drug manufacturer was followed by another hospital supplier, Quad, a Par subsidiary, which had ANDAs approved for 16 different drugs. The firms were also the top two producers of ANDAs for different drugs in 1986. Bolar, which ranked fifth both in terms of total approvals and approvals for different chemical entities, pulled the commercial coup of the 1987 ANDA crop with the August clearance of a generic version of SmithKline's Dyazide. Lederle's Maxzide triamterene/hydrochlorothiazide product also received the first generic competition in 1987. Although not the first to receive approval for a generic version of Lederle's Maxzide, Vitarine (based in Springfield Gardens, NY) was the first firm to come to market with a generic version of the antihypertensive. Vitarine has exclusive generic marketing rights until April 17 under provisions of the Waxman/Hatch law for successfully challenging Mylan's patent assertions ("The Pink Sheet" Dec. 14, p. 14). Vitarine received another significant generic approval during 1987. The firm was first to have an ANDA for a sustained release version of Merck's Indocin (indomethacin) approved. The Colmed Labs subsidiary of Pharmaceutical Basics got two approvals: prazapam (Parke-Davis' Centrax), approved Nov. 6 and Colmed Labs' megestrol acetate (Bristol-Myers' Megace), approved Oct. 2. Other significant approvals include: Barr's tamoxifen (Stuart's Nolvadex), approved March 1; American Therapeutics' clorazepate (Abbott's Tranxene), approved Jan. 8; and Danbury's minoxidil (Upjohn's Loniten), approved March 3. First antibiotic approvals include Zenith's cefadroxil (Mead Johnson's Duricef and Bristol-Myers' Ultrace) and Biocraft's cefadrine (Squibb's Velocef and SmithKline's Anspor). Chart omitted.