First-Time Generic Drug Approvals: August 2011

• Tranexamic Acid Injection 100 mg/mL; packaged in 1000 mg/10 mL single-dose vials
  Approved: August 10, 2011 - Pharmaforce Inc.
  Generic for: Cyklokapron Injection
• Gatifloxacin Ophthalmic Solution 0.3%
  Approved: August 19, 2011 - Apotex Corp.
  Generic for: Zymar Ophthalmic Solution
• Ketoconazole Foam 2%
  Approved: August 25, 2011 - Perrigo Israel Pharmaceuticals Ltd.
  Generic for: Extina Foam, 2%
• Cevimeline Hydrochloride Capsules 30 mg
  Approved: August 25, 2011 - Apotex Inc.
  Generic for: Evoxac Capsules, 30 mg
• Prilocaine Hydrochloride with Epinephrine Injection USP, 4%/1:200,000; packaged in cartridges for dental use
  Approved: August 30, 2011 - Septodont Inc.
  Generic for: Citanest Forte Dental

Generic Approvals Archive