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
FDA Approves Combination Therapy for Pulmonary Arterial Hypertension
March 25th 2024J&J’s Opsynvi is single-tablet combination of macitentan, an endothelin receptor antagonist, and tadalafil, a PDE5 inhibitor. It will be priced on parity with Opsumit, which is also a J&J product to treat patients with PAH.