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News|Articles|May 1, 2009

First-time generic drug approvals, May 2009

Generic drugs approved by FDA (through May 2009) including drospirenone and ethinyl estradiol, levalbuterol, and topiramate

Drospirenone and ethinyl estradiol tablets, 3 mg/0.02 mg (equiv to Yaz tablets)
TEVA

Carbamazepine extended-release tablets, 100, 200, and 400 mg (equiv to Tegretol XR tablets)
TARO

Levalbuterol inhalation solution, 1.25 mg/0.5 mL (equiv to Xopenex inhalation solution)
DEY

Topiramate tablets, 25, 50, 100, and 200 mg (equiv to Topamax tablets)
VARIOUS MANUFACTURERS, INCLUDING TEVA, ZYDUS, UNICHEM, AUROBINDO, INVAGEN, SUN, BARR, ROXANE, GLENMARK, COBALT, APOTEX, MYLAN, CIPLA, PAR, RANBAXY, AND TORRENT

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