First-Time Generic Drug Approvals: February 2008

• Cefuroxime Axetil for Oral Solution USP 125 mg/5 mL and 250 mg/5 mL
  Approved: February 5, 2008 Ranbaxy Pharmaceuticals, Inc.
  Generic for: Ceftin for Oral Suspension
• Famotidine, Calcium Carbonate, Magnesium Hydroxide 10 mg/800 mg/165 mg Chewable Tablets
  Approved: February 6, 2008 Perrigo R&D Company
  Generic for: Pepcid Complete
• Alendronate Sodium Tablets USP, 5 mg (base), 10 mg (base), and 40 mg (base) for Once-Daily Dosing; and 35 mg (base) and 70 mg (base) for Once-Weekly Dosing
  Approved: February 6, 2008 Teva Pharmaceuticals USA; Barr Laboratories, Inc. (70 mg Once-Weekly only)
  Generic for: Fosamax Tablets
• Pramipexole Dihydrochloride Tablets 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 1.5 mg
  Approved: February 19, 2008 Barr Laboratories, Inc.
  Generic for: Mirapex Tablets
• Irinotecan Hydrochloride Injection 20 mg/mL; packaged in 40 mg/2 mL and 100 mg/5 mL single-use vials
  Approved: February 20, 2008 Watson Laboratories, Inc.
  Generic for: Camptosar Injection
• Cetirizine HCl and Pseudoephedrine HCl Extended-Release Tablets 5 mg/120 mg
  Approved: February 25, 2008 Teva Pharmaceuticals USA
  Generic for: Zyrtec-D Extended-Release Tablets
• Calcium Acetate Capsules 667 mg (equivalent to 169 mg calcium)
  Approved: February 26, 2008 Roxane Laboratories, Inc.
  Generic for: Phoslo Gelcaps
• Granisetron Hydrochloride Oral Solution 2 mg (base)/10 mL
  Approved: February 28, 2008 Cypress Pharmaceutical, Inc.
  Generic for: Kytril Oral Solution, 2 mg/10 mL

Generic Approvals Archive