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  The Tan Sheet
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   Full-text available via subscription Subscription journal
   ISSN (Print) 1530-1206
   Published by Informa plc Homepage  [13 journals]
  • Mutual Alleges Mucinex Monopoly By RB In
           Extended-Release Category
    • Abstract: Mutual Pharmaceutical alleges in an antitrust suit that RB attempts to monopolize the extended-release guaifenesin OTC category with its Mucinex product. The suit says Mutual has lost “tens of millions” due to RB's failure to honor a contract to supply an “authorized generic” of the product.
      PubDate: Wed, 04 Mar 2015 00:05:01 -050
       
  • Executive Decisions Roundup: Vitamin Shoppe, MusclePharm
    • Abstract: Watts heads Vitamin Shoppe; Cavanaugh leads MusclePharm branding.
      PubDate: Wed, 04 Mar 2015 00:00:02 -050
       
  • Postage Due: FDA Stamps Spiked Supplement On International Packages
    • Abstract: Most products identified in public notifications contain weight loss or ED drugs, but two contained fluoxetine, for treating depression, bulimia and obsessive-compulsive, panic and premenstrual dysphonic disorders. Using personal mail for commercial shipments is some importers only chance of getting products in the U.S.
      PubDate: Tue, 03 Mar 2015 00:00:04 -050
       
  • Weekly Trademark Review Feb. 24, 2015
    • Abstract: OTC drug, personal care product and nutritional supplement trademark filings compiled by “The Tan Sheet” from Official Gazette of the U.S. Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps; and Class 5 – Pharmaceuticals.
      PubDate: Mon, 02 Mar 2015 00:02:29 -050
       
  • Consumer Health New Products Roundup: Ganeden Biotech, AIDP, Prometheon
           Pharma, MusclePharm
    • Abstract: Ganeden rolls out 14 probiotic products; AIDP in digestive health; Follicept competes against hair regrowth drugs; MusclePharm flexes in energy drinks; and more new products in brief.
      PubDate: Mon, 02 Mar 2015 00:02:24 -050
       
  • EuroPharma Curamin Claims Again Fail Review –
           ERSP
    • Abstract: EuroPharma discontinues claims that its Curamin pain relief supplement is “up to 10 times” stronger, but substantiates establishment claims and discontinued links from the founder’s blog to the firm’s website.
      PubDate: Mon, 02 Mar 2015 00:02:17 -050
       
  • FDA Asked To Clear Air After New York Supplement Enforcement Cloud
    • Abstract: Sens. Hatch and Heinrich ask FDA to explain quality control and testing requirements that federal regulations impose on supplement manufacturers and whether the agency endorses DNA barcoding in identity testing.
      PubDate: Mon, 02 Mar 2015 00:02:10 -050
       
  • Freeing FDA User Fees From Sequestration Proposed Again In Congress
    • Abstract: House members again make a bipartisan bid to prevent FDA user fees from being withheld in a potential sequestration as the Obama administration and Congress come to loggerheads over the fiscal 2016 budget.
      PubDate: Mon, 02 Mar 2015 00:02:06 -050
       
  • Bayer Eyes Restructuring After Selling Material Sciences Unit
    • Abstract: The German multinational’s five recently launched pharmaceutical products are expected to continue to drive growth in 2015, while its transformation in to a life sciences-focused company should be completed by mid-2016 at the latest after it chooses between either an IPO or a spinoff for its material sciences division.
      PubDate: Mon, 02 Mar 2015 00:00:51 -050
       
  • Intent Of La Compana Spanish Ad Lost In Translation
    • Abstract: Genomma Lab USA featured unsupported claims in an ad comparing its La Pomada de la Compana with competing antibiotic ointments, NAD says. While the firm says it did not intend to make a superiority claim, NAD points out a firm is responsible for advertising “messages it did not intend to convey.”
      PubDate: Mon, 02 Mar 2015 00:00:43 -050
       
  • Wireless OKU Device ‘Sees Below Skin’s
           Surface’ To Assess Health
    • Abstract: Touted as a “personal skin coach,” the new OKU device launching soon from mySkin Inc. connects to iPhones and scans users’ skin to analyze its needs, offering recommendations for improvement.
      PubDate: Mon, 02 Mar 2015 00:00:02 -050
       
  • A Tale Of Two Expectations: NDI Notification Estimate And Guidance
    • Abstract: FDA’s estimates for supplement manufacturers’ burden for submitting NDI notifications continue to miss the mark widely, say trade group executives. The agency would be more on target, they say, with a revised draft guidance on NDI notifications expected to reflect stakeholders’ suggestions.
      PubDate: Fri, 27 Feb 2015 00:05:00 -050
       
  • NBTY Targets Unleashing Growth From Private Label Drag
    • Abstract: “Where we have opportunities to hold on to” private label business, “we'll hold on to it, but not at any cost,” says President and CEO Steve Cahillane. “Due to private label margins” becomes common refrain in NBTY’s income downturn.
      PubDate: Thu, 26 Feb 2015 00:05:02 -050
       
  • Industry Roundup: U.K. Product News; FDA Warning Letters; Vitamin Shoppe
           Flexes Online; Herbalife ‘Transition’ Year Ends
    • Abstract: U.K. proposes nonprescription Otrivine spray; more than usual suspects in warning letters; Nexafed tests extended release in pilot; Vitamin Shoppe flexes online strength; Herbalife cautious in guidance; and more consumer health news in brief.
      PubDate: Thu, 26 Feb 2015 00:00:52 -050
       
  • FDA Denies Remaining Sunscreen TEAs, Offers Primer On GRASE, Resources
    • Abstract: FDA denies sunscreen TEAS for L'Oreal and Merck & Co., citing data gaps, according to proposed orders. Proponents of launching additional ingredients say the decisions point to continued gridlock in changing FDA’s OTC sunscreen monograph.
      PubDate: Wed, 25 Feb 2015 00:05:00 -050
       
  • Alli Return In U.S. Fattens Glaxo’s Consumer
           Outlook
    • Abstract: GSK Consumer Healthcare says alli would be available starting Feb. 25 in most stores in the U.S. and Puerto Rico in “improved tamper-evident packaging.” Despite the product’s checkered history, its return marks another boost for Glaxo’s consumer outlook.
      PubDate: Wed, 25 Feb 2015 00:00:12 -050
       
  • FDA Denies Remaining Sunscreen TEAs, Offers Primer On Why They Fail
    • Abstract: In proposed orders to be published Feb. 25, FDA rejects L'Oreal USA’s time and extent application for ecamsule and Merck & Co.’s TEA for enzacamene. Division of Nonprescription Clinical Evaluation Director Theresa Michele realizes the decisions “may be disappointing to some.”
      PubDate: Tue, 24 Feb 2015 11:05:00 -050
       
  • PTO Disarms P&G Head & Shoulders
           Patent Claims After Unilever Salvo
    • Abstract: A PTO appeals board finds two patents crucial to market-leading sales of P&Gs Head & Shoulder shampoo largely are “unpatentable” because a similar product was available when they were filed. Unilever petitioned for a review of the patents as the firm finds new angles in its ongoing patent battle with P&G.
      PubDate: Tue, 24 Feb 2015 00:05:01 -050
       
  • Reviews Between Parties Look Inviting For Consumer Health Patent Disputes
    • Abstract: Inter partes reviews, one of two types of proceedings that PTO allows post-issuance of a patent, are limited to addressing validity challenges based on the “anticipation” or “obviousness” of an invention in view of a prior-art publication.
      PubDate: Tue, 24 Feb 2015 00:00:03 -050
       
  • Bayer Probiotic Claim Defense Argues FTC Wants Substantiation Standard
           That ‘Did Not Exist’
    • Abstract: DoJ says Bayer is avoiding answering requests for details on research that substantiates claims for Philip’s Colon Health and asks a judge to “resolve this matter.” Bayer says it has answered DoJ’s interrogatories, stating it could not comply with FTC’s alleged “standard because it did not exist until” the complaint was filed.
      PubDate: Mon, 23 Feb 2015 00:05:23 -050
       
  • FDA Recalls For Feb. 17, 2015
    • Abstract: Recalls reported by FDA for OTC drugs, nutritionals and personal care products.
      PubDate: Mon, 23 Feb 2015 00:05:17 -050
       
  • Weekly Trademark Review Feb. 17, 2015
    • Abstract: OTC drug, personal care product and nutritional supplement trademark filings compiled by “The Tan Sheet” from Official Gazette of the U.S. Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps; and Class 5 – Pharmaceuticals.
      PubDate: Mon, 23 Feb 2015 00:04:02 -050
       
  • FDA Personnel Growth Could Have Plateaued For Drugs Program
    • Abstract: Only a handful of new FTEs are requested in President Obama’s FY 2016 budget request for human drugs activities, suggesting that GDUFA and other related programs may have reached their critical mass of employees for now.
      PubDate: Mon, 23 Feb 2015 00:03:43 -050
       
  • Consumer Health New Products Roundup: Rite-Aid Skin Care, Elysium’s
           Basis, Totally Hemp Beverages
    • Abstract: Rite-Aid launches skin care line; Basis is fundamental launch for Elysium; first run of drinks for Totally Hemp; StrongGirl line reaches stores; and protein pancake from SDC.
      PubDate: Mon, 23 Feb 2015 00:03:34 -050
       
  • Industry Roundup: P&G Streamlining, Sunscreen TEA Challenges;
           Nutrient ‘Shortfalls’ On Dietary Guideline Report
    • Abstract: P&G plans deeper cuts in streamlining; sunscreen TEA changes challenge CDER; 10 nutrient “shortfalls” on Dietary Guideline report; Spanish-Chinese probiotic partnership; more news in brief.
      PubDate: Mon, 23 Feb 2015 00:01:50 -050
       
 
 
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