New and Generic Drug Approvals
March 24, 2011
Aztreonam Injection, Bedford Laboratories, Approval
Briellyn (Norethindrone and Ethinyl Estradiol) Tablets, Glenmark
Generics Inc., Approval
Eszopiclone Tablets, Orchid Healthcare, Tentative Approval
Ifex (ifosfamide) Injection, Baxter Healthcare Corporation, Labeling Revision
Lamivudine Tablets, TEVA Pharmaceuticals, Tentative Approval
Latanoprost Ophthalmic Solution, Alcon Research, Ltd., Approval
Latanoprost Ophthalmic Solution, Apotex Inc., Approval
Latanoprost Ophthalmic Solution, Bausch and Lomb, Inc., Approval
Latanoprost Ophthalmic Solution, Mylan Pharmaceuticals Inc., Approval
Latanoprost Ophthalmic Solution, PharmaForce, Inc., Approval
Lidocaine Hydrochloride Jelly, Hi-Tech Pharmacal Co., Inc., Approval
Nexavar (sorafenib tosylate) Tablets, Bayer HealthCare
Pharmaceuticals, Inc., Labeling Revision
Simponi (Golimumab) Injection, Centocor Orto Biotech, Inc., Labeling Revision
Torsemide Tablets, Vintage Pharmaceuticals, Approval
March 23, 2011
Doryx (doxycycline hyclate) Delayed-Release Tablets, Mayne
Pharmaceuticals International Pty, Ltd., Labeling Revision
Doryx (doxycycline hyclate) Delayed-Release Tablets, Mayne
Pharmaceuticals International Pty, Ltd., Labeling Revision
Fanapt (iloperidone) Tablets, Novartis Pharmaceuticals Corporation,
Labeling Revision
Fareston (toremifene citrate) Tablets, GTx Inc., Labeling Revision
Humulin R (insulin human [rDNA origin]) Injection, Eli Lilly and
Company, Labeling Revision
Oxycodone and Aspirin Tablets, Watson Laboratories, Inc., Approval
Ranitidine Oral Solution, Hi-Tech Pharmacal Co., Inc., Approval
Tamiflu (oseltamivir phosphate) Capsules, Hoffmann-La Roche, Inc.,
Labeling Revision
Tamiflu (oseltamivir phosphate) Oral Suspension, Hoffmann-La Roche,
Inc., Labeling Revision
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