The FDA has stepped up efforts to combat what it sees as the No. 1 pharmaceutical marketing compliance problem, said Division of Drug Marketing, Advertising and Communication chief Thomas Abrams: ads that omit or downplay risk information.
Merck has responded to an FDA “approvable” letter for Arcoxia (etoricoxib), an investigational selective Cox-2 inhibitor, with results of the MEDAL program.
The halt of Pfizer’s torcetrapib program has potentially far-reaching implications for the broader industry and raises questions about safety of other drugs in its class, analysts said.
Wyeth and the FDA are warning healthcare professionals about an overdose potential for patients taking the antidepressant Effexor.
Eli Lilly says it will appeal the FDA’s decision to issue an “approvable letter” that requests an additional efficacy study for Arxxant, its new drug for moderate to severe nonproliferative diabetic retinopathy.
The FDA says development of a potentially life-threatening serotonin syndrome may occur in treatment with four selective serotonin reuptake inhibitors.
The FDA says it is continuing its battle against unapproved drugs with a consent decree signed with one manufacturer of unapproved drugs and Warning Letters sent to four others.
A Bayer admission that it “mistakingly” did not submit new risk information to the FDA on antibleeding drug Trasylol underscores the agency’s struggle to get critical drug safety information out to the public.
DDMAC says two promotional pieces for Reliant Pharmaceuticals’ Rythmol SR were false or misleading because they failed to include any risk information and they broadened the indication for the product.
