OverTheCounterToday

This Week In OTCs And Nutritionals: FDA Weighs Rulemaking To Realize New Switch Paradigm

The March 26 issue of "The Tan Sheet" offers a front-row view of last week's FDA public hearing on the proposed "new paradigm" for nonprescription drug access.

We've got in-depth coverage and analysis of what agency officials think is needed to expand the possibilities for OTC switch, as well as what major industry players like GlaxoSmithKline could bring to the table.

This week's edition also looks at Procter & Gamble's "New Chapter" in consumer health products, what OTC firms should know about social media and why adolescent consumers have such a hard time obtaining emergency contraception.

For much more, and "The Tan Sheet's" March 26 table of contents, click here.

 

"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.

Your company or organization may already provide access to "The Tan Sheet." To find out if you should have access, email custcare@elsevier.com.

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

 

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

"The Tan Sheet": FDA To Tackle Critical Generics Issue In Switch Paradigm Debate

 

"The Tan Sheet" is your go-to source for coverage and analysis of FDA's proposed "new paradigm" for approving nonprescription pharmaceuticals under conditions of safe use. In advance of the agency's March 22-23 public hearing, check out the below story on what innovative switches could mean for drug innovators and their generic counterparts.

Get the most in-depth reporting on the OTC pharma and nutritional industries in "The Tan Sheet." Your free trial subscription begins here -- no credit card required.

Your company or organization may already provide access to "The Tan Sheet." To find out if you should have access, email custcare@elsevier.com.

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

This Week In OTCs And Nutritionals: Long Road For FDA's New Nonprescription Paradigm, Prestige Rebuffs Genomma, Glaxo Sheds European OTCs

On Thursday and Friday this week, FDA convenes its highly anticipated public hearing on innovative routes to nonprescription drug status. "The Tan Sheet's" March 19 issue continues to delve into the mechanics behind this "new paradigm" and the challenges ahead.

This week we also check in with Prestige Brands' efforts to resist Genomma Lab's unsolicited takeover bid and GlaxoSmithKline's latest OTC divestments, which did not include weight-loss drug alli.  

Additionally, we've got stories on state anti-meth laws, nutritional marketing to the millennial generation, and Teva Pharmaceutical Industries' legal argument for Plan B One-Step OTC market exclusivity.

For much more, and "The Tan Sheet's" full March 19 table of contents, click here.

 

"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.

Your company or organization may already provide access to "The Tan Sheet." To find out if you should have access, email custcare@elsevier.com.

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

 

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

"The Tan Sheet": Consumers Challenge DMAA Safety After DOD Bans Products

 

This free story is brought to you by "The Tan Sheet," 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.

Your company or organization may already provide access to "The Tan Sheet." To find out if you should have access, email custcare@elsevier.com.

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

This Week In OTCs And Nutritionals: Generics In New Switch Paradigm, J&J's Latest OTC Delay, Possible NDI Legislation

This week's issue of "The Tan Sheet" looks at what FDA's proposed "new paradigm" for nonprescription drug access might mean for the generic versions of innovative switches, given that current law would allow equivalents to bypass voluntary access restrictions and just go completely OTC. 

Inside, we've got stories on Johnson & Johnson's struggles to return recalled OTCs to market under its consent decree with FDA and congressional supplement boosters considering legislation to bring FDA's new dietary ingredient draft guidance in line with DSHEA if the agency declines to pull back on the controversial document. There's also a feature on supplement firm ChromaDex and its pharma-like approach to product development.

For much more, and "The Tan Sheet's" full March 12 table of contents, click here.

 

"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.

Your company or organization may already provide access to "The Tan Sheet." To find out if you should have access, email custcare@elsevier.com.

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

 

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

"The Tan Sheet": E-Cigarette Firm Targets Harm Reduction In Therapeutic Claim

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

“The Tan Sheet” Mar. 5, 2012, Vol. 20, No. 10

Venture capital firm Advent Life Sciences invested in U.K. startup CN Creative Ltd. to try to fundamentally change the OTC nicotine replacement therapy market with an electronic inhaler indicated for smoking cessation.

CN Creative’s promotion of harm reduction – a strategy for decreasing the number of people with diseases or other health problems linked to smoking tobacco, as opposed to strictly targeting cessation of smoking or all use of nicotine – is central to Advent’s interest, the investment firm says.

Advent led CN Creative’s first financing round, which raised $3.1 million (£2 million), the firms said Jan. 25. CN Creative will request regulatory approval for its Nicadex electronic nicotine inhaler as an NRT and already markets EVOlution e-cigarettes in Europe and the U.S. through its Intellicig business.

The timing may be right, though some experts predict that in the U.S., FDA will continue to oppose e-cigarettes and harm reduction. But legal changes have opened FDA more to considering harm reduction indications.

To continue reading this story, click here.

 

"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.

This Week In OTCs And Nutritionals: OTC Anthrax MedKit, E-Cigarette Harm Reduction, FTC Vs. Garden Of Life

In addition to in-depth coverage of FDA's notice of a public hearing to consider a "new paradigm" for OTC pharmaceutical access, this week's issue of "The Tan Sheet" features stories on an upcoming FDA advisory committee meeting to discuss OTC home-use anthrax MedKits and an electronic cigarette company that aims to make harm-reduction/nicotine-replacement therapy claims.

"The Tan Sheet" also looks at a federal court's ruling that went in favor of supplement firm Garden of Life and against the Federal Trade Commission. We've got updates on Abbott, Colgate-Palmolive and Procter & Gamble, too.

For much more, and "The Tan Sheet's" full March 5 table of contents, click here.

 

"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)