FDA approves additional strengths of Actavis’ generic Wellbutrin SR
MORRISTOWN, N.J. Actavis has received regulatory approval from the Food and Drug Administration for a generic antidepressant, the drug maker announced Wednesday.
Actavis said it immediately will begin distributing its bupropion HCl extended-release (SR) tablets in 100-mg and 200-mg strengths. The drug is the generic equivalent of GlaxoSmithKline’s Wellbutrin SR. Actavis already has marketed generic Wellbutrin SR in the 150-mg strength. The drug maker received approval in March 2008.
Annual U.S. sales of Wellbutrin SR 100-mg and 200-mg and the generic equivalent in that strength was $115 million for the 12 months ended in March, according to IMS Health data.
Pfizer suspends more tanezumab trials
NEW YORK Drug maker Pfizer is suspending some clinical studies of a biotech drug for treating pain following reports of harmful side effects in patients, Pfizer said Monday.
The drug maker halted studies of the drug tanezumab in patients with chronic low back pain and painful diabetic peripheral neuropathy at the request of the Food and Drug Administration.
Pfizer said the suspension follows further consideration of reports of harmful side effects in osteoarthritis patients taking the drug. The company already had suspended the osteoarthritis study of tanezumab in June.
PCMA responds to government funding anti-fraud programs
WASHINGTON The leader of a group representing the nation’s pharmacy benefit managers responded to a House subcommittee’s decision to allot $561 million for programs designed to combat fraud, waste and abuse.
Pharmaceutical Care Management Association president and CEO Mark Merritt said the decision shows “it’s more important than ever to enhance America’s overall program integrity capabilities.” The money was provided to the Department of Health and Human Services, the Centers for Medicare and Medicaid Services and the Justice Department.
“The administration has noted that these kinds of efforts can save almost $10 billion,” Merritt said. “The other side of the anti-fraud coin is that policymakers must reject policies that inadvertently weaken the ability of public and private payers to detect and prevent waste, fraud and abuse. It’s far easier to prevent fraud than to engage in ‘pay and chase’ activities after the fact.”