Untitled Letter

OPDP joins Amarin's Vascepa tale

OPDP joins Amarin's Vascepa tale

By

An untitled letter from the FDA's bad-ad unit shows Amarin's triglyceride-lowering medication faced multiple challenges in 2013.

OPDP not happy with Diclegis promo

OPDP not happy with Diclegis promo

By

The bad-ad watchdog issued an untitled letter to drugmaker Duchesnay in November.

Researcher finds black-box drugs have high Warning Letter risk

EyeonFDA finds that, when it comes to black-boxed drugs' marketing materials, the FDA is more likely to issue Warning Letters than untitled letters.

Merz web-copy shortcuts don't sit well with OPDP

By

FDA's Office of Prescription Drug Promotion issued an Untitled Letter over what it says are misleading copy and overstated efficacy claims online.

Business briefs: GlaxoSmithKline and Spectrum

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.

Xarelto print ad puts Janssen in hot water

Xarelto print ad puts Janssen in hot water

By

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.

Business briefs: Aveo, Dynavax, Gilead, OPDP

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.

With untitled letter, FDA signals press materials aren't exempt

By

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.

Pfizer, Valeant and Acorda hit with untitled letters

Pfizer, Valeant and Acorda hit with untitled letters

By

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.

Sobi, Watson get OPDP untitled letters

Sobi, Watson get OPDP untitled letters

By

The FDA's Office of Prescription Drug Promotion served Sobi and Watson with untitled letters.

Lipitor.com gets Bad Ad slap for cross-promotion sans risk info

By

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).

Boniva print ad hyped efficacy, says DDMAC

Boniva print ad hyped efficacy, says DDMAC

By

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.

DDMAC enforcement letters up 26% in 2010

DDMAC enforcement letters up 26% in 2010

By

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.

DDMAC pokes Allergan on eye drop direct mail

DDMAC pokes Allergan on eye drop direct mail

By

Allergan has a superiority complex when it comes to marketing its ophthalmic drops, as evidenced by a second DDMAC Untitled Letter posted online yesterday.

DDMAC slaps Alcon convention graphic

DDMAC slaps Alcon convention graphic

By

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.

DDMAC slaps Premarin patient testimonials, Acuvail journal ad

DDMAC slaps Premarin patient testimonials, Acuvail journal ad

By

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.

Dendreon draws CBER letter for Provenge professional marketing

By

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.

Novartis Facebook Share widget provokes DDMAC letter

By

A Facebook Share widget found on Novartis' Tasigna website provoked a DDMAC Untitled Letter, the fourth DDMAC communiqué Novartis has received this year.

Intuniv patient kit draws DDMAC untitled letter

Intuniv patient kit draws DDMAC untitled letter

By

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.

Sepracor's 'boxing bed' ad hit with DDMAC untitled letter

Sepracor's 'boxing bed' ad hit with DDMAC untitled letter

By

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.

GSK awareness ad for Arzerra a stealth product promotion, says FDA

GSK awareness ad for Arzerra a stealth product promotion, says FDA

By

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.

FDA says competing biologic ads both misled

By

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.

Email Newsletters