Mylan’s nebivolol receives approvable letter from FDA, efficacy not at issue
NEW YORK Mylan’s new anti-hypertension drug has received a nearly green light from the Food and Drug Administration.
While an approvable letter from the FDA did not raise any questions related to safety or efficacy of nebivol, a novel beta blocker, Mylan and its licensing partner, Forest Laboratories, did report that final marketing approval would depend on the duo’s ability to resolve deficiencies in its manufacturing facility in Belgium, issues which the letter addressed.
At this time, the companies and the FDA have agreed upon product labeling text and the proposed brand name is currently Bystolic.
The companies anticipate an expeditious resolution to this issue, and Forest continues to plan for a Jan 2008 launch meeting for Bystolic.
RPCS to expand $3 generics program to Food Pyramid
SPRINGFIELD, Mo. A regional, employee-owned company is set to celebrate the successful one-year anniversary of its $3 generic drug program by expanding its services.
RPCS, based in Springfield, Mo., launched its $3 generics program last year at its 20 pharmacies located inside the corporation’s four regional chains: Ramey, Price Cutter, Price Cutter Plus and Smitty’s grocery stores.
For Black Friday this year, the company debuted a similar program at nine pharmacies in Food Pyramid stores in the Tulsa area.
The $3 price applies to specific generic drugs with up to a 30-day supply of commonly prescribed dosages. Quantities over 30 days or above recommended common dosages will be at usual and customary pricing.
Since its launch, RPCS’ pharmacists have filled more than 100,000 prescriptions.
“Senior citizens, as you would imagine, make up a large portion of customers taking advantage of the program,” Larry Storey, pharmacy administrator for RPCS, said. “However, we’ve found that everyone appreciates saving money. We’ve filled $3 generics for people from all walks of life and all age groups. We’ve actually saved the customer anywhere from $5 to $20 for each prescription on the list.”
The top five generics that customers are purchasing on the program are metformin, used to treat diabetes; hydrochlorothiazide, diuretic for cardiac patients; levothyroxine, for thyroid patients; lisinopril, to treat high blood pressure; and amoxicillin, an antibiotic.
UCB files application with FDA for new pain reliever
BRUSSELS, Belgium Belgian pharmaceutical group UCB said on Thursday that it has filed a drug application with the Food and Drug Administration for its pain-relieving drug, according to Reuters.
Lacosamide, designed to treat epilepsy and pain associated with diabetic neuropaths, was filed to become an additional therapy in the treatment of partial onset seizures in adults with epilepsy and includes three formulations—tablets, syrup and intravenous injection, UCB said in a statement.
The drug’s proposed trade name is Vimpat.
UCB made a similar filing with the European Medicines Agency earlier this year, Reuters reported. The Belgian company already has blockbuster drug Keppra to treat epilepsy, although patent protection is set to expire in the United States by January 2009 and in Europe in May 2010.
Reuters also reported that the company’s other drug, with the proposed trade name Rikelta, is in Phase III trials to treat epilepsy and genetic epilepsy disorder Unverricht Lundborg Disease, while lacosamide is in Phase II trials for fibromyalgia, migraine prophylaxis and osteoarthritic pain.
UCB had also sought approval from the U.S. authorities for lacosamide to treat adults with diabetic neuropathic pain in tablet formation. The condition is often described as causing patients to feel a stabbing and burning sensation in the legs, feet or hands. Close to 7.7 million Americans suffer from the condition.