OverTheCounterToday

This Week In OTCs And Nutritionals: FDA Considers “New Paradigm” To Switch More Rx Drugs

We added to our web site a breaking news alert that FDA is considering a “new paradigm” for approving new drugs to facilitate making more Rx products available nonprescription, according to a notice for a March 22-23 public hearing.

Our Feb. 27 issue offers in-depth analysis of Prestige Brands Holdings’ response to Genomme Labs’ unsolicited acquisition offer. “The Tan Sheet” also explains why some firms are using the GRAS affirmation process instead of submitting supplement NDI notifications, and why Rx-only requirements might not be the solution to prevent purchases of pseudoephedrine drugs to make methamphetamine.

Click here for a full table of contents from our Feb. 27 issue.

 "The Tan Sheet" is your source for the most comprehensive and in-depth coverage of the OTC drug and nutritional industries. Start your free trial subscription here -- no credit card required.

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– Malcolm Spicer (m.spicer@elsevier.com)

 

This Week In OTCs and Nutritionals: A McNeil Recall, GMP Personnel Violations, The Market For Nutritionals In China

In this week's presidential edition of "The Tan Sheet," McNeil recalls an infants' Tylenol product due to dosing device problems, recent supplement GMP warning letters show personnel management is often the source of violations and China is a hot market for nutritional sales. 

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.

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. 

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. 

This blog is brought to you by "The Tan Sheet," your go-to weekly source for OTC and nutritional news and analysis. For information on a free 30-day trial subscription, click here -- no credit card required.

Also, follow "The Tan Sheet" on Twitter and Facebook.

This Week In OTCs And Nutritionals: Perrigo, Reckitt Benckiser, Primatene Mist, Supplement Trends

This week's issue of "The Tan Sheet" features a story on congressional demands that FDA release an existing supply of OTC asthma inhaler Primatene Mist. We've got a look at the Center for Reproductive Rights' revised lawsuit on the Plan B emergency contraceptive, as well as a story on supplement sales trends for 2012.

There's also insight into the quarterly earnings reports of Perrigo, Reckitt Benckiser, Dr. Reddy's Laboratories, Church & Dwight and more.

Click here for a full table of contents from our Feb. 13 issue.

 

"The Tan Sheet" is your source for the most comprehensive and in-depth coverage of the OTC drug and nutritional industries. Start your free trial subscription here -- no credit card required.

Also, follow "The Tan Sheet" on Twitter and Facebook.

 

- Dan Schiff (d.schiff@elsevier.com)

OTC/Nutritional News From "The Tan Sheet": Advocates Refile Plan B Lawsuit; Plan B Available in University Vending Machine; Korea’s Wider OTC Access Stalls

This Week In OTCs And Nutritionals: FDA Inspects Novartis, Pfizer Likes Consumer Fit, CHPA Quantifies OTCs' Value

The Feb. 6 issue of "The Tan Sheet" examines the recent inspection report that suggests FDA influenced Novartis Consumer Health's decisions to cease production at its Nebraska facility in December and recall OTC products in January.

As earnings season continues, we look at Pfizer's plans for its consumer health business -- which increased sales 8% in the fourth quarter -- once it divests the nutritionals and animal health segments.

Elsewhere in this week's edition, we delve into a study sponsored by the Consumer Healthcare Products Association to reveal the full economic value of OTC drugs. Additionally, we've got stories on Johnson & Johnson's latest consumer personnel changes, a follow-up on FDA's pediatric review of Plan B One-Step, and a cover story on the agency's tendency to make broad policy statements via guidance documents -- such as the new dietary ingredient notification draft.

 

This blog is brought to you by "The Tan Sheet," your go-to weekly source for OTC and nutritional news and analysis. For information on a free 30-day trial subscription, click here -- no credit card required.

Also, follow "The Tan Sheet" on Twitter and Facebook.

OTC/Nutritional News From "The Tan Sheet": J&J Personnel Changes, Vitacost Brand Overhaul, PPI Fracture Study

 

This news roundup is brought to you by "The Tan Sheet," your go-to weekly source for OTC and nutritional news and analysis. For information on a free 30-day trial subscription, click here -- no credit card required.

Also, follow "The Tan Sheet" on Twitter and Facebook.