FDA approves Mylan’s drug for treating epilepsy
PITTSBURGH Mylan announced Tuesday that the Food and Drug Administration had approved its application to manufacture and market levetiracetam tablets.
The company was the first to file an approval application, meaning that it has the exclusive right to market the tablets for six months. The tablets are a generic version of UCB Pharma’s epilepsy drug Keppra and will be available in strengths of 250 mg, 500 mg and 750 mg.
Mylan and UCB had previously entered an agreement to settle pending litigation relating to levetiracetam. Under the settlement, Mylan was given the right to market the tablets in the three strengths as early as Nov. 1, provided that UCB got the exclusive right to market the drug for use in children and the FDA approved Mylan’s application. UCB will retain pediatric exclusivity for Keppra until Jan. 14.
FDA approves Treanda for treatment of Hodgkin’s disease
FRAZER, Pa. The Food and Drug Administration has approved a drug for treating non-Hodgkin’s lymphoma, the drug’s manufacturer announced Monday.
Cephalon announced the agency’s approval of its drug Treanda (bendamustine hydrochloride), an injection for treating indolent B-cell NHL that has progressed up to six months following treatment with Rituxan (rituximab), made by Genentech and Biogen Idec, or a drug regimen that includes Rituxan.
Indolent NHL is a cancer of the lymphatic system that is not curable and often relapses after initial therapy. It affects about 30,000 people in the United States each year, according to the National Cancer Institute.
“Because most patients with indolent non-Hodgkin’s lymphoma eventually become resistant to existing treatments, new treatment options like Treanda are needed to improve patient outcome,” Georgetown University medicine professor and Treanda clinical investigator Bruce Cheson said in a statement.
PharmaSmart to grow its blood pressure management systems in U.S. market
ROCHESTER, N.Y. PharmaSmart International announced last week its intent to penetrate the U.S. market with its blood-pressure management program that has already enjoyed acceptance in the Canadian marketplace, boasting 75 percent penetration.
“Our goal as a company is to change the paradigm in community blood pressure screening,” stated Ashton Maaraba, PharmaSmart’s global vice president of sales and marketing. “We have committed significant resources to ensuring our clients execute at every level, delivering a turnkey program that delivers on the massive blood pressure management opportunity.”
Unlike existing blood pressure programs, which may primarily act as vehicles for third party advertising, PharmaSmart proposes to convert the hypertensive patient into a revenue-generating opportunity, and retain that consumer with an exclusive, pharmacy-branded BP management program, the company stated.
PharmaSmart’s blood pressure management tools and programs allow pharmacies to capitalize on the hypertension opportunity. PharmaSmart’s branded Smart Card offers pharmacists a long-term management tool for their patients that has been found to improve hypertension discovery, consultation, and prescription compliance, all significant challenges in the fight against hypertension, Maaraba noted.
PharmaSmart’s “pharmacy first/patient first” platform seeks to augment the patient-pharmacist relationship through an education program—both point-of-sale training and continuing education—for pharmacists and pharmacy technicians around hypertension. The program includes PharmaSmart’s patented blood-pressure cuff, patient Smart Card management tool, and a patient web portal.
In Canada, PharmaSmart is present in Rexall, Shoppers Drug Mart, Wal-Mart Canada, Loblaws, Le Group Jean Coutu, Safeway Canada and Calgary Coop, among other pharmacies.