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Executive Summary

FDA approved 30 NDA efficacy supplements in 1990, the same number as in 1989, according to FDA's most recent figures on the NDA review process. Data compiled by FDA for the recently-issued annual "Offices of Drug Evaluation: Statistical Report" show that there was also little change in the number of efficacy supplements submitted in 1990 compared to the previous year -- 42 and 41, respectively -- as well as in the total amount pending: 122 versus 125. The 122 pending efficacy supplements are a significant improvement from March 1986, the initial tracking date, when 208 were on file. In addition to the 30 approvals, 14 efficacy supplements were "approvable" by FDA at the end of 1990 and 15 were not approvable. Another 23 were withdrawn. The average time between submission and approval was a little under three years (34 months); new indications averaged a 50-month review. Exactly half of the efficacy supplement approvals in 1990 were for new indications, including Burroughs Wellcome's Zovirax (acyclovir) for herpes zoster (with a seven-year FDA review period) and herpes simplex encephalitis (five-year review). Upjohn's Xanax (alprazolam) panic disorder indication required a 39-month review for approval. The only Rx-to-OTC switch was Schering-Plough's Gyne-Lotrimin (clotrimazole) for vaginal yeast infections, which was approved after 29 months. Original NDA filings dropped below 100 for the first time in over 10 years, with 98 submissions sent to the agency in 1990. The pharmaceutical industry consistently has scaled back on original NDAs in six of the past seven years, with a 12.3% average annual decrease in the number of filings from 1983 to 1990. FDA had 213 NDAs pending at the 1990 year-end, an improvement over the 1989 pending total of 239 and the lowest level since 1986. The number of "overdue" new drug applications pending rose slightly by the end of 1990 to 71 from the year-earlier 67; "overdue" NDAs are those pending beyond FDA's statutory 180-day review period. While NDAs are tapering off, the number of IND submissions is on the rise. There were 1,530 INDs filed in 1990, a 13.8% increase over the previous year. Commercial INDs received by FDA in 1990 totaled 376, compared to 308 in 1989. FDA's nine drug review divisions had a combined total of 2,931 commercial INDs pending in 1990 and 9,604 overall. The 333 INDs submitted to the Division of Metabolism and Endocrine Drug Products in 1990 (including 66 for commercial drugs) was the largest amount among the nine divisions and pushed M&E ahead of the Neuropharmacological Drugs Division in terms of having the highest IND workload at FDA. The Metabolism and Endocrine division now has 1,820 active INDs, 376 of which are commercial. The Neuropharmacological division, which headed the IND workload in 1988 and 1989, had the next highest level of pending INDs with 1,662; of those, 343 were for company-sponsored trials. The Division of Anti-Infective Drug Products continues to have the most commercial INDs pending, with 546, followed by the Oncology and Pulmonary Drugs Division (439) and the Division of Cardio-Renal Products (421). A breakdown of 1990 NDA approvals by division shows that Anti- Infectives led the way with 24 approvals, five of which were for new molecular entities. Oncology/Pulmonary approved eight NDAs, including 5 NMEs; Metabolic/Endocrine also issued eight approvals, including 2 NMEs.

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