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FDA APPROVES 23 NEW MOLECULAR ENTITIES IN 1990 FOR SECOND YEAR IN A ROW; NDA REVIEWS TOOK AN AVERAGE OF 30 MONTHS, "A"-RATED DRUGS REVIEWED IN 17 MONTHS

Executive Summary

FDA approved 23 new molecular entities in 1990 -- equal to the agency's effort in 1989 and slightly better than the number of total NME approvals in 1986, 1987 and 1988. FDA finished the year with a strong December burst, approving 11 new molecular entities in the last three weeks of 1990. However, FDA may have raised some expectations. Noting that FDA "chug[s] out about 20 (NMEs) in a typical year," FDA Center for Drug Evaluation and Research Director Carl Peck told a Nov. 8-9 meeting of the Edwards Committee's Subcommittee on Drugs and Biologics, that "we're expecting to surprise you this year" ("The Pink Sheet" Nov. 19, p. 7). FDA had approved 11 NMEs at the time of Peck's prediction. The 12 approvals in FDA's November-December rush were just enough to bring the 1990 total to historical levels. December 1990 was just slightly busier than December 1989 when FDA approved 10 NMEs. FDA's pre-approval inspection program would have been expected to have an adverse effect on the number of drugs approved at year- end. However, FDA dropped its policy of requiring product-specific inspections before drugs could be approved in late fall. Now, FDA says that product-specific inspections will only be conducted if a company has had GMP problems or a facility has never been inspected for production of a certain type of product. However, the approval of Glaxo's Zofran on Jan. 4, which was held up by labeling discussions, may indicate additional holdovers into the new year (see story p. 3). A number of products nearing the end of FDA review did not make it through FDA during the agency's end-of-the-year rush, including Bristol-Myers Squibb's Pravachol, Pfizer's sertraline, Genzyme's Ceredase, Fison's Tilade and Berlex' Fludara I.V. In addition, several new molecular entities with significant commercial potential continue to languish at the agency, such as Schering-Plough's Claritin, SmithKline Beecham's Relifex, and Wyeth-Ayerst's Lodine. The NME approvals in 1990 took an average of 30 months or about 2-1/2 years, from filing to final approval. The average 1990 approval time is somewhat better than the 1989 average approval time of 33 months (see chart below). The quickest review times were for Burroughs Wellcome's Exosurf Neonatal, approved in six months, Janssen's Ergamisol (levamisole), cleared in eight months, and Pfizer's Diflucan (fluconazole), approved in 11 months (see chart on p. 10-11 for complete listing of 1990 approvals and approval times). All three drugs were classified by FDA as representing important therapeutic advances. Exosurf is the first lung surfactant approved for treating and preventing respiratory distress syndrome in infants. Approval for the synthetic lung surfactant came just 10 days after an approval recommendation by an FDA advisory committee. Ergamisol was approved for use in combination with 5-fluorouracil as an adjuvant treatment to surgery in Dukes' C colon cancer. Diflucan carried FDA's "1AA" rating, which is a high priority designation given by the agency to AIDS therapies. The synthetic once-daily broad spectrum antifungal was approved for treatment of two AIDS related fungal infections -- cryptococcal meningitis and candidiasis. The seven "1A" and "1AA" products were approved in an average of 17 months, compared to 31 months for the four "1B" drugs, and 38 months for the 12 "1C" drugs. The drugs that received the longest review times were McNeil's anti-anginal agent Vascor (bepridil HCl), Abbott's sedative/hypnotic ProSom (estazolam), Sandoz' anti-hypertensive DynaCirc (isradipine), and Pfizer's anti-hypertensive Cardura (doxazosin mesylate). Both Vascor and ProSom took seven years to reach approval from initial NDA filing dates. DynaCirc took four years and eight months to approve and Cardura waited 44 months for approval. The long approval times for Vascor and ProSom may have been due to safety concerns and/or subsequent requests for further data. Vascor's NDA was filed in December 1983. The drug's progress through the review process was apparently thwarted in 1986, when FDA's Cardio-Renal Drug Advisory Committee voted not to recommend approval for Vascor because of safety concerns. To support approval, the committee requested data showing some advantage over other anti-anginal agents (see story, p. 4). ProSom's NDA had been pending at FDA since 1983. The drug's approval may have been delayed by FDA requests for more data (see p. 13). At the agency's request, Abbott filed, in late 1988, the results of a safety study of patients receiving both ProSom and Halcion. DynaCirc's NDA approval was apparently delayed by FDA requests for more data. Sandoz submitted its NDA for DynaCirc in April 1986. The firm subsequently filed FDA-mandated peak-trough studies in the fall of 1988. At the time of a December 1987 co- promotion agreement between Sandoz and Glaxo for DynaCirc, Glaxo had predicted a 1988 approval. Unlike the others, Cardura's approval was reportedly held up at the last minute because of FDA's pre-approval inspection program. The inspection of Pfizer's manufacturing processes for Cardura took place after Oct. 1; the drug was approved on Nov. 2. FDA also approved several significant supplemental NDAs in 1990, including the use of ICI's Nolvadex as an adjuvant in treating node-negative breast cancer. In May, Marion Merrell Dow's Carafate (sucralfate) gained a maintenance indication for healed ulcers. The drug was originally approved for short-term treatment of duodenal ulcers. Upjohn's Xanax (alprazolam) received supplemental approval for treatment of panic disorder in November. In addition, FDA approved the Rx-to- OTC switch of Schering's Gyne-Lotrimin (clotrimazole) in November for the treatment of yeast infections. EDITORS' NOTE: 1990 approval times are calculated by "The Pink Sheet" from dates of submission as reported by FDA or sponsors, to dates of approval. Averages for years 1980-1989 are taken from FDA statistical reports, which also rely on date of original submission to date of final approval. Neither calculation takes into account periods of time when the applications were not under active review. Chart omitted.
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