Watson seeks FDA approval for generic Renvela, confirms patent challenge
MORRISTOWN, N.J. Generic drug maker Watson Pharmaceuticals hopes to be the first to market a version of a kidney disease treatment made by Genzyme, Watson said Monday.
Watson said it filed a regulatory approval application with the Food and Drug Administration for sevelamer carbonate for oral suspension. The drug is a generic version of Genzyme’s Renvela, used to control serum phosphorus in patients with chronic kidney disease who are on dialysis.
Watson’s application included a Paragraph IV certification, a legal assertion that the patents covering Renvela are invalid, unenforceable or won’t be infringed by a generic version, prompting Genzyme to file a patent infringement suit in the U.S. District Court for the District of Maryland. Watson’s case puts a stay of final FDA approval of Watson’s product for two and a half years or until the two companies resolve the matter before the court.
In May, Watson also filed for approval of a generic version of Renvela in tablet form.
Diplomat Specialty Pharmacy names new VP operations
SWARTZ CREEK, Mich. Privately owned Diplomat Specialty Pharmacy has hired a new executive to oversee its day-to-day operations, Diplomat said Monday.
The company hired Robert Fleckenstein as VP operations, a position in which he will manage operations at Diplomat’s national distribution center, patient service operations, call center, oncology department and other services at its headquarters, reporting to SVP operations Jeff Rowe.
“It is a very exciting time for Diplomat Pharmacy, and I am very pleased to be part of the team,” Fleckenstein said. “As the individual responsible for operations at the new Great Lakes Biotech Center, I plan to develop the training modules and management tools that allow us to continue to grow efficiencly and effectively without losing sight of the patient-care model and the culture that has allowed us to reach this point.”
Fleckenstein previously served as VP pharmacy operations for Allion Healthcare and VP pharmacy operations at CVS ProCare Mail Service.
NCPA: Other options exist for mail-order pharmacy customers
ALEXANDRIA, Va. Planned cutbacks at the U.S. Postal Service, particularly cancellation of Saturday delivery, have had mail-order pharmacies and patients worried about how patients will get their medications in an efficient and affordable way, but the National Community Pharmacists Association is using the problem as an opportunity to promote independent pharmacies.
“The hand-wringing about what losing a day of mail services means for patients is overblown because common-sense remedies are available through independent community pharmacies,” NCPA acting EVP and CEO Douglas Hoey said. “Evidence suggests that Americans, whether they live in densely or sparsely populated areas, have access to independent community pharmacies that can fill the void, even providing home delivery services.”
The organization sent a letter Monday to U.S. Postal Regulatory Commission chairwoman Ruth Goldway to promote independents as an alternative to mail-order medication delivery.
“NCPA believes that other options exist to ensure patient access to needed medications if changes are made to mail delivery,” read the letter, signed by NCPA SVP government affairs John Coster. “These include eliminating mandatory mail-order programs that deny patients the opportunity to receive medications from their local community pharmacist, as well as utilizing home-delivery programs where community pharmacists deliver medications to the patient’s doorstep.”