New and Generic Drug Approvals (Sep 16):

*Hydralazine Hydrochloride Tablets, Hetero Drugs, Ltd., Approval *KEPPRA XR (levetiracetam) Extended-Release Tablets, UCB, Inc., Approval *Lamivudine and Tenofovir Disoproxil Fumarate Tablets, Matrix Laboratories, Ltd., Tentative Approval *REMODULIN (treprostinil sodium) Subcutaneous I.V. Injection, United Therapeutics Corp., Labeling Revision *SANCUSO (granisetron) Transdermal System, Strakan International, Ltd., Approval *TARCEVA (erlotinib hydrochloride) Tablets, OSI Pharmaceuticals, Inc., Labeling Revision 

New and Generic Drug Approvals (Sep 17):
 
*Galantamine Hydrobromide Extended-Release Capsules, Barr Laboratories, Inc., Approval *LYBREL (levonorgestrel and ethinyl estradiol) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision *Risperidone Tablets, Apotex Corp., Approval *Risperidone Tablets, Mylan Pharmaceuticals, Inc., Approval 


Source: FDA


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