Actavis’ generic Strattera gets OK from FDA
MORRISTOWN, N.J. The Food and Drug Administration has approved a generic drug made by Actavis for treating attention deficit hyperactivity disorder, Actavis said Wednesday.
The FDA approved the drug maker’s atomoxetine hydrochloride capsules in the 10-mg, 18-mg, 25-mg, 40-mg, 60-mg, 80-mg and 100-mg strengths. The drug is a generic version of Eli Lilly’s Strattera, which had $532 million in sales during the 12-month period ended in June, according to IMS Health.
Actavis has not yet set a launch date for the drug, as the U.S. Court of Appeals for the Federal Circuit is reviewing an Aug. 12 ruling that invalidated Lilly’s patent on the drug, which will expire in 2017.
Allergan’s elevated intraocular pressure treatment gets nod from FDA
IRVINE, Calif. Allergan’s optimized reformulation of Lumigan has received approval from the Food and Drug Administration, the drug maker said Wednesday.
Lumigan 0.01% (bimatoprost ophthalmic solution) is a first-line therapy indicated for the reduction of elevated intraocular pressure with open-angle glaucoma or ocular hypertension, Allergan said. Lumigan 0.01% will be available in fourth quarter 2010 as the newest addition to Allergan’s comprehensive glaucoma portfolio.
"Lumigan 0.01% exemplifies Allergan’s commitment to developing medications for glaucoma patients that maximize efficacy while minimizing drug exposure,” said Scott Whitcup, Allergan’s EVP research and development and chief scientific officer.
Lilly’s Evista patents upheld in appeals court ruling
INDIANAPOLIS Eli Lilly’s method-of-use patents for its osteoporosis drug were declared valid by a federal court of appeals.
The drug maker said the Court of Appeals for the Federal Circuit has affirmed a prior ruling by the U.S. District Court for the Southern District of Indiana that the company’s patents for Evista (raloxifene HCl tablets) are valid.
“Protection of intellectual property rights is extremely important to the biopharmaceutical industry and the patients we serve. We will continue to vigorously defend our rights, in order to support the development of the next generation of innovative medicines,” said Robert Armitage, SVP and general counsel for Lilly.