The agency says is it time to update the onerous decades-old review process.
A panel is meeting February 10 to discuss revoking the OTC status of some medications.
An FDA committee is poised to review a new Primatene Mist in February.
The company beat consensus estimates, with particular sales strengths from its pharmaceuticals division.
Sanofi pulls GLP-1 diabetes med from FDA review; Gilead files oncology drug; BI/Lilly reveals results of head-to-head trial of its SGLT2 inhibitor vs. Januvia; BI campaign animates heartburn market; Girl Scouts take on mental health
The company is supporting its professional pitch for the acne drug with a micro-targeted marketing strategy.
Sanofi may make OTC history; Celgene joins a new collaboration; and the US Task Force of Preventative Medicine wants to make lung cancer screening the norm
FDA grants Teva three years exclusivity to sell Plan B OTC for all ages; FDA gives Humira a thumbs-down for spondyloarthritis; a UK vaccine committee rejects Novartis' meningitis B shot; and Wockhardt gets a warning letter from FDA for its manufacturing practices at an Indian plant.
Researchers quantify the rate at which doctors, nurses and pharmacists buy off-label OTC drugs.
Bridgette Heller, Merck EVP and president of its consumer care division, adjured life-sci managers to enable women to unleash the full power of their knowledge and ideas to drive growth in the business.
A pair of studies suggests that consumers are hungry for information, and that price determines how patients perceive their risk for life-threatening conditions.
CEO Alex Gorsky said OTC brands are coming back. Meanwhile, pharmaceutical sales provided ballast to the year's numbers.
Rolaids gets a French twist, and Elsevier packs the second week of the year with two news items.
Novo Nordisk has launched a hemophilia app; and a report says the Chinese OTC market is going gangbusters
Novartis is hyping its relaunch of Excedrin with a celebrity spokesperson, a migraine app and a survey of women migraine sufferers - along with print and out-of-home ads, radio promotions, direct mail and social media.
A study of advertising for OTC switches found that presentation of risk information plummeted once the products advertised escaped the purview of the FDA.
GlaxoSmithKline continues to shed businesses, but can't shake its weight-loss drug Alli (orlistat).
Novartis named Brian McNamara as division head of OTC, replacing J&J veteran Naomi Kelman, who spent a year in the role.
GlaxoSmithKline divested North American OTC drugs worth about $200 million in sales, a portfolio that seemed like a good strategic fit for buyer Prestige Brands Holdings.
Jon Bon Jovi is the latest celebrity pitchman for Pfizer Consumer Healthcare's Advil.
Don't tell the New York Post, but Pfizer is boosting bike lanes as part of an Advil promotion.
Pfizer is reportedly weighing an attempt at an over-the-counter (OTC) switch for Lipitor - a move that could help the company recoup some of its losses when the $11 billion drug loses US exclusivity in November -- but the reception from analysts has been muted so far.
Desperate Housewives star Dana Delany will serve as the face of Pfizer's "Women Move the World" campaign for OTC supplement Caltrate. In a twist on the user-generated content formula, she'll invite women to submit their girl power-themed stories to the brand's Facebook page for consideration as advertising fodder
A feminine hygiene brand known for its boffo advertising is back with an anatomically-explicit ad campaign that's generating tons of publicity but also charges of racism.
InVentiv's GSW is going after the consumer health and wellness market with an offshoot, dubbed The Well @GSW, aimed at OTC brands, consumer products and retail accounts.
Teva is partnering with Procter & Gamble in an OTC drug marketing joint venture that will boast annual sales of more than $1 billion -- and which could ultimately be worth four times that, the companies say.
The percentage of women surveyed that said they're buying prescription medications was way up in 2010 - to 64% from 48% in 2009 - a jump the survey's sponsors, Saatchi & Saatchi Wellness and Time Inc.'s Health, said points to a recessionary refocusing on personal health with great potential for healthcare marketers.
GlaxoSmithKline launched new commercials for Alli, in time for New Year's resolutions and holiday overeating remorse, and handed off five OTC products to Meda Pharmaceuticals.
Pfizer Consumer Healthcare is launching an Advil line extension with a contest to win a personal shopper for "Black Friday," the Friday after Thanksgiving, when bargain-hunting holiday shoppers pack stores.
Pfizer took aim at J&J's Tylenol franchise with a campaign offering free Advil and urging consumers to clean out their medicine cabinets and trash recalled drugs.