Drug Criteria & Outcomes: New FDA Approvals
These drugs recently received final approval from the Food and Drug Administration (FDA):
• Mixed salts of a single-entity amphetamine product (ADDERALL XR) by Shire Pharmaceuticals Group. The FDA has approved mixed salts of a single-entity amphetamine product (ADDERALL XR) for the treatment of attention deficit/hyperactivity disorder (ADHD). ADDERALL XR, an extended-release formulation of Shire’s ADHD treatment ADDERALL, is designed to provide symptom control in the morning and throughout the day with just one morning dose.
• New indication for celecoxib capsules (Celebrex) by Pharmacia Corp. and Pfizer. The FDA has approved the use of celecoxib capsules (Celebrex) for the management of acute pain and primary dysmenorrhea in adults. This new indication provides patients the benefit of being able to take an additional dose if needed for individualized relief of acute pain.
• Reformulation of prednisolone tablets USP, 5 mg, by Lannett Co. The FDA has approved the reformulated version of the Lannett’s existing Abbreviated New Drug Application for prednisolone tablets USP, 5 mg, indicated for the anti-inflammatory treatment caused by organ disorders.
• New indication for gatifloxacin by Bristol-Myers Squibb Co. Gatifloxacin (TEQUIN), a broad- spectrum fluoroquinolone antibiotic, has been approved by the FDA for short-course (5-day) regimen in the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB). TEQUIN already is approved for ABECB, acute sinusitis, and community-acquired pneumonia.