Novartis Cleans Up Diovan Promotions
This article was originally published in The Pink Sheet Daily
Company recalls 100,000 bottles of antibacterial soap that were distributed as a promotion for the antihypertensive.
You may also be interested in...
FDA has concerns that the unbranded ad, which is connected to a disease awareness program, too heavily references Novartis. The company has its own concerns that unbranded ads may not be effective in the anti-hypertensive market.
The MARVAL study cited in the sales materials does not demonstrate that the antihypertensive is effective in preserving renal function, FDA's ad division says. The letter preceded Novartis' unveiling of a hypertension disease awareness campaign.
“We are prepared to enter discussions toward a decree at FDA’s earliest convenience,” Able says in letter to FDA. Company is pursuing consent decree instead of responding to FDA Form 483 report citing manufacturing deficiencies. The letter follows CEO Maury’s resignation the previous day.