First-Time Generic Drug Approvals: July 2011

• Fondaparinux Sodium Injection 2.5 mg/0.5 mL, 5 mg/0.4 mL, 7.5 mg/0.6 mL and 10 mg/0.8 mL
  Approved: July 11, 2011 - Dr. Reddy's Laboratories Limited
  Generic for: Arixtra
• Alfuzosin Hydrochloride Extended-Release Tablets 10 mg
  Approved: July 18, 2011 - Apotex Inc.; Mylan Pharmaceuticals, Inc.; Torrent Pharmaceuticals; Teva Pharmaceuticals USA; Sun Pharmaceutical Industries Limited
  Generic for: Uroxatral
• Metronidazole Topical Gel 1%
  Approved: July 22, 2011 - Tolmar, Inc.
  Generic for: Metrogel 1%
• Paricalcitol Injection USP, 2 mcg/mL and 5 mcg/mL
  Approved: July 27, 2011 - Sandoz Canada, Inc.
  Generic for: Zemplar Injection
• Phentermine Resin Complex Extended-Release Capsules 15 mg (base) and 30 mg (base)
  Approved: July 28, 2011 - Lannett Company, Inc.
  Generic for: Ionamin

Generic Approvals Archive