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FDA approves Reckitt Benckiser's Suboxone

   

RICHMOND, Va. (Sept. 2) The Food and Drug Administration has approved Reckitt Benckiser’s treatment for opioid addiction, Reckitt Benckiser said.

The drug maker announced the approval of Suboxone (buprenorphine and naloxone), a drug delivered through a fast-dissolving film placed under the tongue. The film is based on a technology known as PharmFilm, made by MonoSol Rx.

“The development of Suboxone sublingual film through our exclusive agreement with MonoSol Rx reinforces our commitment to our opioid dependence therapy franchise and to its development,” Reckitt Benckiser president Shaun Thaxter said.

Lilly's Evista patents upheld in appeals court ruling

   

INDIANAPOLIS (Sept. 1) 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.

Allergan's elevated intraocular pressure treatment gets nod from FDA

   

IRVINE, Calif. (Sept. 1) 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.

 
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