Schwarz Pharma, part of Belgium´s UCB group, has had Toviaz, their treatment for overactive bladders, approved by the Food and Drug Administration (FDA).
Toviaz (generically fesoterodine fumarate) was the center of a court case between Pfizer and Schwarz Pharma several years back, until in 2006 Pfizer acquired the rights to the drug outright for $ 100 million dollars, and the rights to distribution.
If and once the drug was approved, according to the deal, Schwarz would receive another $ 120 million dollars, and Pfizer should now start paying royalties to the German manufacturer.
Toviaz, approved only for adults, works by relaxing the smooth muscle tissue of the bladder to reduce urinary frequency and leakage of urine, an FDA statement said.
Common side effects include dry mouth and constipation, the agency said. Dry eyes and trouble emptying the bladder were reported less frequently.
The warning on adverse effects states patients with severe liver impairment or uncontrolled, narrow-angle glaucoma should not use the drug.