First-Time Generic Approvals

First-Time Generic Approvals

First Time Generics are those drug products that have never been
approved before as generic drug products and are new generic products
to the marketplace.
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