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.
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