News Briefs: FDA recounts 2001 approvals
News Briefs: FDA recounts 2001 approvals
During 2001, the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research approved 66 new drugs, 24 of which were new molecular entities (NMEs) with ingredients never before marketed in the United States.
Ten of the 66 new drugs (seven of the NMEs) received priority status and were reviewed and approved in the median time of six months. The other 56 approvals were reviewed under a standard status. Their median review time was 12 months (15.7 months for the 17 standard NMEs), and their median total approval time was 14 months (19 months for the NMEs).
The FDA’s Center for Biologics Evaluation and Research reviewed a total of 16 complex biological license applications (BLAs) in the median time of 13.8 months and approved them in the median time of 20.3 months. Two of the BLAs, which were classified as priority products, were reviewed in the median time of 11.5 months and approved in the median approval of 13.2 months. Approvals of 10 of the BLAs, six BLA supplements for new or expanded uses, and three premarket approval applications (PMAs) were considered major actions. Most of the products approved by CBER were designed to detect or treat infectious diseases.
Finally, FDA’s Center for Devices and Radio-logical Health approved 54 PMAs, of which 24 were for devices with novel technologies or new uses. The median total approval time for the 54 products was 11.3 months.
News Briefs: Study: Aspirin as effective as warfarin/aspirin
A new study appearing in the Feb. 5 issue of Circulation found that aspirin alone was as effective as aspirin combined with warfarin, a prescription blood thinner, in reducing the risk of a recurrent heart attack.
The open-label study compared the efficacy of warfarin (target international normalized ratio 1.5-2.5 IU) plus aspirin (81 mg daily) with the efficacy of aspirin monotherapy (162 mg daily) in reducing the total mortality in 5,059 patients enrolled within 14 days of infarction and followed for a median of 2.7 years. Secondary endpoints included recurrent myocardial infarction (MI), stroke, and major hemorrhage.
Four hundred thirty-eight of the 2,537 patients assigned to the aspirin group died, as did 444 of the 2,522 patients assigned to the combination group. Recurrent MI occurred in 333 patients taking aspirin and in 33 patients taking the combination therapy. Stroke occurred in 89 patients taking aspirin and in 79 patients taking the combination therapy.
This research follows another study published last month in the British Medical Journal, which indicated that a significantly lower strength of aspirin — between 75 and 150 milligrams — is just as effective as regular strength 325 mg aspirin, for long-term cardiovascular therapy. This is significant because higher doses of aspirin, while no more effective, are associated with significantly higher risk of serious gastrointestinal side effects.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.