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Executive Summary

Sixteen new chemical entity (NCE) approvals in December transformed 1985 into a record year for NDA reviews. A total of 30 new compounds cleared the agency. FDA surpassed its NCE approval record of 28 set in 1982. Approvals in 1982 had followed a record high of 27 in 1981. The agency's approval activity increased substantially from 1984, when it approved 22 NCEs, and 1983, when it approved only 14 NCEs. As in previous years, FDA approved a large group of drugs at the end of the year. The bulge of approvals in December, 1985, however, were significantly greater in number and relation to total year approvals than any previous year. FDA cleared 16 of its 30 NCEs in December, 1985, compared to eight of 22 in 1984, two of 14 in 1983, and six of 28 in 1982. A number of companies are starting 1986 with the challenge of marketing a drug in a product class new to them. For example, Boehringer-Ingelheim's Mexitil, approved Dec. 30, was the firm's first anti-arrhythmic. Burroughs-Wellcome will be marketing its first anti-depressant following the Dec. 30 approval of Wellbutrin. Genentech's Protropin is the first product to be marketed by the firm's 15-member sales force ("The Pink Sheet" Oct. 21, p. 3). And, Ascot, a generic firm, entered the brandname pharmaceutical business with the Oct. 29 approval of Moctanin. The orphan drug for dissolution of gallstones was launched in November ("The Pink Sheet" Nov. 18, T&G-1). Stuart received its first cephalosporin approval Dec. 27 for Cefotan (cefotetan disodium). The second generation parenteral cephalosporin, approved two years after the January 1984 NDA filing, is indicated for urinary tract infections, lower respiratory infections, ob/gyn infections, intra-abdominal infections, bone and joint infections, transurethral infections, caesarian section, hysterectomy, and gastrointestinal surgery, according to the firm. Stuart licenses the drug from the Japanese firm Yamanouchi. SmithKline subsidiary Allergan received FDA approval for Betagan (levobunolol HCl) Dec. 19., after a two-year NDA review. Labeled indications state that "Betagan liquifilm sterile ophthalmic solution has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma or ocular hypertension." Allergan licensed the drug from Warner-Lambert. Betagan's approval follows by four months approval of another beta adrenergic blocking agent for glaucoma, Alcon's Betoptic (betaxolol HCl) ("The Pink Sheet" Sept. 30, p. 9). Betoptic was the second beta blocker for glaucoma to enter the market, following Merck's Timoptic (timolol) by eight years. In announcing approval of Betoptic, which was classified by FDA as representing a modest therapeutic gain over existing therapies, the firm said one of the product's advantages is that it "exerts little or no effect on lung tissue." Betagan was classified by FDA as representing little or no therapeutic gain over existing therapies. However, Allergan President Gavin Herbert told analysts at the firm's biennial meeting in Philadelphia in 1984 that the firm's specialized sales force and reputation in the glaucoma area could help the compound take "a significant share of this $200 mil. market." Allergan's U.S. detail force currently numbers 125. Amersham Corp. got a December approval for indium IN 111 oxyquinolone, cleared after a 27-month review. The radiodiagnostic is indicated "for radiolabeling autologous leukocytes." The diagnostic was recommended for approval by FDA's Radiopharmaceutical Drugs Advisory Cmte. at a November 1984 meeting. The cmte. recommended that the product only be used in adults and noted that the agent is not the diagnostic method of first choice when the location of infection is known ("The Pink Sheet" Nov. 19, T&G-4). Final labeling states that the imaging agent is "not the preferred technique for the initial evaluation of patients with high clinical probability of an abscess in a known location" and that it should only be used in children when the benefit "exceeds the risk" of the "high radiation burden." Roche is also researching the compound. Other December approved NCEs include J&J's Suprol (suprofen), Lilly's Cesamet (nabilone), Merck's Vasotec (enalapril), Sterling's Omnipaque (iohexol), Squibb's Isovue (iopamidol), and Viratek's Virazole (ribavirin) (see stories in "The Pink Sheet" Jan. 6). The remaining December approvals are: Boehringer Ingelheim's Mexitil (mexiletine HCl), Burroughs-Wellcome's Wellbutrin (buproprion), Glaxo's Temovate (clobetasol propionate), Roche's Versed (midazolam) and Schering's Dormalin (quazepam). Merck had the most NCE approvals in 1985 with a total of three: Vasotec, approved Dec. 24 for the treatment of "hypertension of all degrees of severity"; Cuprid (trientine), an orphan drug approved Nov. 8 for the treatment of Wilson's Disease ("The Pink Sheet" Dec. 2, p. 12), and the broad spectrum antibiotic, Primaxin (imipenem/cilastin), approved Nov. 26 ("The Pink Sheet" Dec. 2, p. 6). Merck was followed in most 1985 NCEs by SmithKline, Glaxo and Syntex, each with two new products. In addition to Betagan, SmithKline received approval for Ridaura (auranofin). The oral gold product was approved May 24 as secondary treatment for rheumatoid arthritis patients unresponsive to one or more nonsteroidal anti-inflammatory drugs ("The Pink Sheet" May 27, T&G-1). Glaxo received approval for Temovate on Dec. 27 and Fortaz (ceftazidime) on July 19. Subsequently, Lilly received approval of an ANDA for the third generation cephalosporin ("The Pink Sheet" Nov. 25, p. 5). The two new products give Glaxo a total of five cleared in the last three years. As with 1984, FDA's Anti-Infective Div. was the most active in approving NCEs, clearing eight products during the year. The Cardio-Renal Div. and Oncology and Radiopharmaceutical Div. followed, each with six new drugs. FDA approved three "A" drugs (i.e., drugs with an important therapeutic gain) in 1985, compared with two in 1984 and four in 1983. Genentech received an "A" classification for its October approved Protropin (somatrem) ("The Pink Sheet" Oct. 21, p. 3). American Home Products' Cordarone, (amiodarone) got an "A" rating as a potentially life saving agent for treating arrhythmias unresponsive to all other therapy ("The Pink Sheet" Jan. 6, p. 7). The third "A" drug is Viratek's Virazole. The Dec. 31 approved antiviral aerosol product is indicated for severe respiratory infections in infants caused by respiratory syncytial virus. While "A" drugs did not vary much from preceeding years, the number of drugs classified as representing at least a modest therapeutic gain, "B" drugs as well as "A" drugs, was significantly higher than in previous years. Eighteen of the 30 drugs approved by FDA received an "A" or "B" classification in 1985. In 1984, 10 of the 22 drugs approved were designated as "A" or "B" drugs; five of 14 drugs received that rating in 1983, and nine of 28 in 1982. On the generic side, FDA approved 194 ANDA applications for post-1962 drugs during the year. The number of post 1962 approvals climbed steadily as the year progressed; the generic division approved an average of four per month in the first quarter of the year, nine in the second quarter, 21 in the third quarter, and 30 in the final quarter. The increasing post-1962 approval rate was in part due to additional staff positions added after enactment of the ANDA/patent restoration law, and in part to the approval of a large number of pending pre-1962 ANDA applications. Chart omitted.

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