OverTheCounterToday

Happy New Year From "The Tan Sheet"!

 

From all of us at "The Tan Sheet," enjoy a happy and healthy new year. We look forward to 2012, our 20th year of publishing(!), as we continue to provide you with the latest and most insightful coverage of the nonprescription pharmaceutical and nutritional industries.

See below for the top stories from the Dec. 19 issue, our final of 2011. For a complete table of contents, and to sign up for a free trial subscription, click here -- no credit card required.

Also, follow the latest OTC drug and nutritional news via "The Tan Sheet" on Twitter and Facebook.

Deja Vu All Over Again: McNeil Recalls Motrin Product

McNeil Consumer Healthcare’s voluntary recall of 12 million bottles of its Motrin product marks the third consecutive year the Johnson & Johnson business ended the year recalling an OTC drug product.

In a Dec. 21 statement on the Motrin website, McNeil said it is recalling from retailers 59 lots of Motrin IB coated caplets and tablets in 24-count containers and coated caplets in 24+6-count packages -- each product contains 200 mg ibuprofen. The firm said testing of samples showed some caplets may not dissolve as quickly as intended when the products near their expiration date. The lots are being recalled "since there is a chance they could experience a similar problem as they approach expiration,” the J&J business said.

Don't get caught out in the cold. Make "The Tan Sheet" your go-to weekly source for OTC and nutritional news and analysis. For 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: A Cold Front Chills Industry

The temperatures outside are dropping, but Jack Frost is not responsible for the cooling relationship between FDA and the dietary supplement industry. Trade groups respond icily to new dietary ingredient notification draft guidance that they say contravenes the Dietary Supplement Health and Education Act. Most groups agree FDA should rewrite the guidance, but “The Tan Sheet” combs through individual comments to highlight the finer points.

HHS Secretary Sebelius also sent a chill through the drug industry when she blocked Teva Pharmaceutical Industry’s attempted full OTC switch of emergency contraceptive Plan B. We look at why Sebelius overrode FDA’s recommendation to make the pill available OTC to all females of childbearing age, and analyze the potential impact the interference could have on future switch attempts and the potential creation of a third drug class.

We also look at FDA’s enforcement priorities for the New Year and its progress on foreign food facility inspections.

Don't get caught out in the cold. Make "The Tan Sheet" your go-to weekly source for OTC and nutritional news and analysis. For a free 30-day trial subscription, click here. No credit card required. Also, follow "The Tan Sheet" on Twitter and Facebook.

HHS Overrules FDA On Plan B OTC, Sends Teva Back To Drawing Board

This news update is brought to you by "The Tan Sheet," your source for the most in-depth news and analysis from the world of OTC drugs and nutritionals. For information on a 30-day free trial subscription, click here. No credit card required.

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Health and Human Services Secretary Kathleen Sebelius overrules FDA in denying Teva Pharmaceutical Industries’ request to make the Plan B One-Step emergency contraceptive available OTC.

Sebelius says in a Dec. 7 letter to FDA Commissioner Margaret Hamburg the label comprehension and actual use data submitted by Teva in its February supplemental new drug application do not fully cover younger consumers for which Plan B One-Step (levonorgestrel 1.5 mg) would be available without a prescription.

"The Tan Sheet" previously reported on Teva's OTC application here. 

This Week In OTCs And Nutritionals: Trade Groups Rip NDI Guidance, Perrigo’s Prevacid Push-Back, GAO Finds Adulteration Disconnect At FDA

The reviews are in for FDA's new dietary ingredient notification draft guidance, and they aren't pretty. In comments submitted to the agency late last week, the Council for Responsible Nutrition and Consumer Healthcare Products Association call for the controversial guidance to be pulled and rewritten. The Natural Products Association also takes issue with FDA's "overstepping" of the Dietary Supplement Health and Education Act. This week's "Tan Sheet" has the details.

Our Dec. 5 issue also has an exclusive look at Perrigo's citizen petition to FDA that would, in effect, create obstacles for competing generic versions of Novartis' Prevacid 24HR OTC proton pump inhibitor.

Elsewhere in Tan, we describe what went into Embria Health Sciences' successful NDI submission for its EpiCor ingredient, review the Government Accountability Office's recommendations for FDA's economic adulteration initiatives, and catch up with NBTY's efforts to expand in the sports nutrition category.

 

Make "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.