FDA increases the pace of new drug introductions
March 1, 1997 less than 1 minute read
FDA increases the pace of new drug introductions
For better or worse, the U.S. Food and Drug Administration has dramatically tightened the time it takes for a new drug to be reviewed. Since 1990, the average approval time has been halved — from 30 months to 15. It takes even less time, on average, to get a drug approved these days for a life-threatening illness. Twenty-seven such products met that definition last year; average approval time: eight months.
All told, the agency approved 121 drugs last year, including 46 products never sold in the United States. Among the latest approvals:
• Zanaflex (tizanidine): an alpha-2 stimulant to treat spasticity from multiple sclerosis and spinal injuries;
• Levaquin (levofloxacin) and Zagram (sparfloxacin): new fluoroquinolones to fight over with your P and T Committee;
• Topamax (topiramate): a new seizure medication;
• Lipitor (atorvastatin): yet another cholesterol-reducing drug;
• Diovan (valsartan): another angiotensin II blocker;
• Microzide (hydrochlorothiazide): old reliable hits the market in a once-daily capsule form.
And take note, the FDA now says Prilosec (omeprazole) can be used as first-line therapy for heartburn and reflux, and Ceftin (cefuroxime) has been OK’d for use in the early stages of Lyme disease.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content