EyeonFDA finds that, when it comes to black-boxed drugs' marketing materials, the FDA is more likely to issue Warning Letters than untitled letters.
FDA's Office of Prescription Drug Promotion issued an Untitled Letter over what it says are misleading copy and overstated efficacy claims online.
GSK sees a regulatory setback on its once-weekly GLP-1 med, and Spectrum Pharma gets hit with an untitled letter from OPDP on a sales aid for Zevalin.
The bad-ad group has hit the drug maker with an untitled letter, saying the print piece's type treatment and other elements mislead patients.
Aveo CRL says company's kidney drug information is uninterpretable; Dynavax has to find more hepatitis B clinical trial patients; Gilead's hep C drug gets priority status; OPDP slaps Janssen and Sigma Tau with untitled letters.
The FDA has issued a rare untitled letter concerning a pitch letter - a reminder that the agency does not consider press materials to be exempted from its oversight.
The drug industry may be settling in for a hot, lazy summer, but FDA's Office of Prescription Drug Promotion has been keeping busy, issuing untitled letters to Pfizer, Valeant and Acorda Therapeutics over allegedly violative promotions in recent weeks.
The FDA's Office of Prescription Drug Promotion served Sobi and Watson with untitled letters.
Pfizer's Lipitor website touted the efficacy of Caduet, Chantix and Norvasc but failed to balance those claims with risk info for the drugs, according to an "untitled letter" from FDA's Division of Drug Marketing, Advertising and Communication (DDMAC).
A print ad for Genentech's Boniva overstated the osteoporosis drug's efficacy, said the FDA's Division of Drug Marketing, Advertising and Communication in an untitled letter.
The FDA's Division of Drug Marketing, Advertising and Communications has written 26% more enforcement letters to drug companies over promotional practices this year than it did in 2009.
Allergan has a superiority complex when it comes to marketing its ophthalmic drops, as evidenced by a second DDMAC Untitled Letter posted online yesterday.
A convention graphic for Alcon's Travatan Z, an ophthalmic drop, broadened the product's indication and made unsubstantiated superiority claims, according to a Division of Drug Marketing, Advertising and Communications (DDMAC) Untitled Letter.
Patient testimonial videos on the brand.com homepage for Wyeth's (now Pfizer's) Premarin overstated the drug's efficacy and minimized risks, while a journal ad for Allergan's Acuvail made unsubstantiated superiority claims, overstated efficacy, broadened the drug's indication, and omitted risk information, according to a pair of untitled DDMAC letters.
The Center for Biologics Evaluation and Research hit Dendreon with an untitled letter for false and misleading professional marketing materials for its prostate cancer treatment Provenge.
A Facebook Share widget found on Novartis' Tasigna website provoked a DDMAC Untitled Letter, the fourth DDMAC communiqué Novartis has received this year.
Patient materials for Shire's ADHD drug Intuniv presented unsubstantiated effectiveness and superiority claims and downplayed important risk info, said the FDA's Division of Drug Marketing, Advertising and Communication.
A 60-second TV ad for insomnia drug Lunesta, which portrayed a woman fighting for sleep in a bed-turned-boxing ring, drew an untitled letter from regulators.
The FDA scolded GlaxoSmithKline over a disease-awareness ad that failed to mention side effects but alluded to newly approved cancer treatment Arzerra. It's a sign the agency is construing the exemption for disease-awareness promotions quite narrowly.
One is a sales aid, and one is a consumer brochure, but both ads -- for CSL Behring's Zemaira and for Talecris' Prolastin -- are false or misleading, FDA said in a pair of untitled letters.