Today's News

Prestige Brands Stock Climbs On Genomma’s Unsolicited Bid / The Mexico City-based pharmaceutical and personal care products company’s unsolicited bid to pay Prestige $16.60 per share, excluding debt, represents a 23% premium over the consumer product firm’s previous trading day’s closing price of $13.50 a share. / “The Tan Sheet”

Regulatory

Personnel Management A Missing Ingredient In Many GMP Violations / During dietary supplement good manufacturing practices inspections, FDA officials look at how a company handles its ingredient components, in-process products and how it manages personnel. When agency inspectors enter a facility they want to see the quality control personnel, their qualifications and training records. / “The Tan Sheet” Feb. 20, 2012

Regulatory News In Brief / Orlistat benefits outweigh risks, EMA says; J&J, Energizer to study SPF 85; Health Canada warns about Miracle Mineral Solution; Regencea recalls RegenArouse; more Regulatory News In Brief / “The Tan Sheet” Feb. 20, 2012

Dietary Supplements

China Leads Emerging Markets Poised For Strong Nutrients Sales Growth / Global sales of nutrients, herbals, minerals and vitamins should reach $23.7 billion by 2015, according to the Freedonia Group. Firms seeking to cash in on this growth should consider China, where sales will surpass the U.S. by 2020, making it the largest national market for nutraceuticals. / “The Tan Sheet” Feb. 20, 2012

BRIC Nutraceutical Ingredient Demand Grows / Global sales of nutraceutical ingredients by 2015 will reach $23.7 billion, according to market research firm the Freedonia Group ("China Leads Emerging Markets Poised For Strong Nutrients Sales Growth" — "The Tan Sheet," Feb. 20, 2012). The fastest growing market will be China, where demand should surpass the U.S. by 2020. Across emerging markets, led by Brazil, Russia and India in addition to China, the fastest growing nutrients will include proteins, fibers and functional additives, Freedonia forecasts. (Figures in millions.) ... / “The Tan Sheet” Feb. 20, 2012

National Advertising Division In Brief / Barlow drops claims after NAD opens review; ingredient testing is not enough for EyeScience; Direct Digital supports joint health claims; Suncore supports cookie claims. / “The Tan Sheet” Feb. 20, 2012

People

Matrixx Appoints Scerene Healthcare Executive To Lead Turnaround / M’lou Arnett talks about how her experience, including designing the “Mr. Mucus” advertising icon for the Mucinex cough treatment line, has prepared her for the challenge of growing Matrixx’s revenues in the wake of removing the Zicam gel and swab products from the market. / “The Tan Sheet” Feb. 20, 2012

People In Brief / Roberts to lead Nature’s Sunshine; Heel nabs P&G vet; von Eschenbach chairs FDA Project; Perrigo promotes Gallagher in regulatory affairs; more People in Brief. / “The Tan Sheet” Feb. 20, 2012

OTCs

McNeil Recalls Liquid Infants’ Tylenol With Dosing Device Problem / McNeil Consumer Healthcare recalls an Infants’ Tylenol product that returned to market in November, after receiving consumer complaints about a problem with the SimpleMeasure dosing device system. The recall marks a misstep in the J&J subsidiary’s comeback from OTC quality control issues. / “The Tan Sheet” Feb. 20, 2012

Teva Breaks Out OTC Sales Figures In Bid To Play Up Diversification / Teva Pharmaceutical Industries reported OTC product sales for the first time Feb. 15. The Jerusalem firm said OTC net revenue was $765 million in 2011, up 54.2% and attributable largely to the acquisition of German firm ratiopharm and the PGT Healthcare joint venture with Procter & Gamble. / “The Tan Sheet” Feb. 20, 2012

Korean Committee Recommends Bill Allowing OTC Supermarket Sales / The law could go into effect as early as August to allow sales of 20 types of OTC drugs – painkillers, cold medicines, digestive products and fever reducers – beyond the traditional outlet of pharmacies. / “The Tan Sheet” Feb. 20, 2012

FDA

FDA Proposes Expanding User Fees To Cosmetics Among New Areas / The White House requests a 17% increase in FDA’s overall budget to $4.5 billion, including $855 million in direct appropriations for CFSAN, about $10 million less than its fiscal 2012 appropriation, and $473 million for CDER, about $5 million less than its current appropriation. / “The Tan Sheet” Feb. 20, 2012

Battle Lines Clear On Conflict Of Interest Policy In PDUFA Reauthorization / Commissioner Hamburg says the agency likely does not need legislation to improve its conflict of interest policy, but House members still say the system needs reform. Industry and patient advocate groups push for change, while consumer groups press FDA to stand firm. / “The Tan Sheet” Feb. 20, 2012

Sales & Earnings

Sales & Earnings In Brief / GNC passes $2B in annual revenue; launches lift Watson earnings; NAI benefits from FDA supplement crackdown; PuraMed turns corner with LipiGesic M product rollout. / “The Tan Sheet” Feb. 20, 2012

Business & Finance

In Brief / FDA extends phytosterol enforcement discretion; Perrigo debuts Claritin-D 12 Hour equivalent; Reckitt sells Indian personal care brands acquired from Paras; Ocean Nutrition Canada gets vertical; more news In Brief. / “The Tan Sheet” Feb. 20, 2012

Recalls

FDA Recalls For Feb. 15 / FOODS - CLASS III AquaActive Negative ORP & Alkaline Tablet With Added Inulin & L-Leucine Contains Four Essential Electrolytes 60 Effervescent Tablets 230mg FDA Registered Medical Device 3008514084 All lots distributed from 11/01/2010 - 12/16/2011 Manufacturer: Good Herbs, Inc., Troy, MI ... / “The Tan Sheet” Feb. 20, 2012

Trademarks

Weekly Trademark Review Feb. 14, 2012 / [Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) compiled by “The Tan Sheet” from Official Gazette of the U.S. Patent and Trademark Office] Product Name Trademark No./ [Serial No.] Company Filed Date [Published] Class Nos. / “The Tan Sheet” Feb. 20, 2012