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Journal Cover Consumer Drugs
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   Full-text available via subscription Subscription journal
   ISSN (Print) 1530-1206
   Published by Informa plc Homepage  [9 journals]
  • Primatene Mist NDA Expected By July After FDA OKs OTC Asthma Inhaler Trial
    • Abstract: Amphastar plans this month to begin what it expects to be its final study to support an NDA to relaunch...      Related Stories
      Off-Label Communications: US FDA Won?t Impede Discussions With Payers, Gottlieb Says
      Celebrex CV Risk v. Naproxen, Ibuprofen: US FDA Does Not Recommend Differential Labeling
      Recent And Upcoming FDA Advisory Committee Meetings 
      PubDate: Fri, 20 Apr 2018 15:28:59 GMT
       
  • P&G Adds Merck's Brands, Expands Consumer Health
           Categories, Footprint
    • Abstract: P&G’s planned acquisition of Merck KGaA’s consumer health care business will grow its consumer health portfolio 50%, expand its OTC...      Related Stories
      Recent And Upcoming FDA Advisory Committee Meetings
      CMDh Steps In As Firm Finds No Takers To Replace UK As Reference Member State
      CJEU Ruling Clarifies Roles Of Member States And Courts In Determining Data Exclusivity 
      PubDate: Thu, 19 Apr 2018 21:37:56 GMT
       
  • J&J Consumer Health On Solid Footing With Help From Personal Care
           Sales
    • Abstract: Analysts say firm’s consumer health division is showing signs of a comeback, with worldwide sales up 5.3% to $3.4bn, boosted...      Related Stories
      Recent And Upcoming FDA Advisory Committee Meetings
      CMDh Steps In As Firm Finds No Takers To Replace UK As Reference Member State
      CJEU Ruling Clarifies Roles Of Member States And Courts In Determining Data Exclusivity 
      PubDate: Tue, 17 Apr 2018 18:43:52 GMT
       
  • PEG 3350 Laxatives: FDA Allows Firms 6 Months To Make Their Case For Rx
           Products
    • Abstract: FDA agrees with Breckenridge Pharmaceutical, Nexgen Pharma, Lannett Co. and Paddock Labs that ending availability of their Rx PEG 3350...      Related Stories
      European Pharmacopoeia Revives Gene Therapy Panel To Update Decade Old Monograph
      Brexit Won’t Delay Drug Approvals, EMA’s Rasi Reassures Industry
      US FDA Developing Database Of Medical Review Decisions, Gottlieb Tells Congress 
      PubDate: Tue, 17 Apr 2018 16:50:14 GMT
       
  • Rx PEG Firms Give FDA Deadline Before Asking Court To Delay ANDA
           Withdrawals
    • Abstract: Breckenridge Pharmaceuticals and Nexgen Pharma file a citizen petition asking FDA to delay effective date for the agency?s order that...      Related Stories
      ?Right-To-Try? Has US FDA Support: Scaled-Back House Bill Retains Agency Oversight
      Pediatric Studies Of Systemic Atopic Dermatitis Drugs Should Start Earlier, US FDA Says
      Drug Industry Raises ‘Green’ Concerns Over Forthcoming EU Environment Strategy 
      PubDate: Thu, 12 Apr 2018 14:33:41 GMT
       
  • Sensodyne Whitening Claims Receive Dim Review From UK Regulator
    • Abstract: Advertising Standards Authority reviewed claims GSK?s GlaxoSmithKline Consumer Healthcare Trading Ltd. made online for Sensodyne True White after a Colgate-Palmolive...      Related Stories
      Hong Kong Looks To EU For New Advanced Therapy Rules
      EMA Consults On Extrapolation Considerations For Antibacterial Agents To Treat Pediatrics
      Pacira?s Exparel Adds Nerve Block Indication For Shoulder Surgery In US 
      PubDate: Mon, 09 Apr 2018 16:57:41 GMT
       
  • P&G Could Be Last Suitor Standing For Pfizer's Consumer
           Health Business
    • Abstract: A spin-off still is an option for Pfizer, as is continuing to operate the unit as it currently does. But...      Related Stories
      EMA Taking Steps To Mitigate ‘Critical’ Product Shortages Due To GMP Problems
      Manufacturing Compliance Updates In Brief: A Reduced Focus On Data Integrity?
      Recent And Upcoming FDA Advisory Committee Meetings 
      PubDate: Thu, 05 Apr 2018 16:38:43 GMT
       
  • Differin Extends With Cleanser, Moisturizer, Biore Adds Foam In OTC Skin
           Care
    • Abstract: Galderma Labs receives FDA approval for new labeling for its OTC Differin acne treatment and launches cleanser and moisturizer under...      Related Stories
      New Executive Director Takes Seat At Swiss Medicines Agency
      Ouch! US Lashes Out At China With New Tariffs On Selected Drugs, APIs
      Benefit-Risk Frameworks May Be Coming To US FDA Advisory Committees 
      PubDate: Mon, 02 Apr 2018 17:54:03 GMT
       
  • Consumer Health Sector Holds Private Equity Investors' Attention
    • Abstract: "It?s amazing with this consumer empowerment how fast that market is growing," biopharma industry veteran Fred Hassan remarks. "Coming up...      Related Stories
      Keeping Track: Submissions Galore, Blincyto Supplemental Approval, And Priority Review For Opdivo/Yervoy Combo
      Waiting For Next Regulatory Shoe To Drop For Takeda?s Gout Drug Uloric
      Breakthrough Status Arrives Late In Development Of Yervoy+Opdivo, Enfortumab Vedotin And Pedmark 
      PubDate: Fri, 30 Mar 2018 10:24:30 GMT
       
  • Glaxo Opts For Solo Navigation To Boost Control In Consumer Health Market
    • Abstract: After announcing the $13bn acquisition of Novartis? 36.5% share of their JV, GSK said its Horlicks nutritional beverage line and...      Related Stories
      EMA Raises Industry Fees: Now Almost €287,000 For A New Drug Approval
      Australia Proposes Mandatory Reporting To Fix ?Major Failings? Of Medicines Shortages Initiative
      EMA Strengthens Warnings For Retinoids, Starts Probe Into Omega-3 Fatty Acid Medicines 
      PubDate: Tue, 27 Mar 2018 18:25:48 GMT
       
  • Sensitivity To Flu Helped OTC Drug Firms End 2017 With Sales Boost
    • Abstract: Cold and flu products performed “extraordinarily strong” wherever an influenza virus hit hardest, demonstrating “how understanding key incidents can really...      Related Stories
      UK MHRA ?Could Set Up Standalone System? But Faces Post-Brexit Loss Of Income & Influence
      European CHMP Opinions And MAA Updates
      New Zealand Proposes First Increase In Regulatory Fees Since 2006 
      PubDate: Mon, 26 Mar 2018 15:31:52 GMT
       
  • GSK And Reckitt Opting Out Of Pfizer's Consumer Business Sale
           Speaks Volumes
    • Abstract: Reckitt and GSK withdraw from negotiating on potential deals for with Pfizer?s consumer business, leaving slim chances Pfizer will receive...      Related Stories
      UK MHRA ?Could Set Up Standalone System? But Faces Post-Brexit Loss Of Income & Influence
      European CHMP Opinions And MAA Updates
      New Zealand Proposes First Increase In Regulatory Fees Since 2006 
      PubDate: Sun, 25 Mar 2018 14:49:08 GMT
       
  • Shorter Exclusivity In House OTC Monograph Bill Could Gain Industry
           Acceptance To Speed Passage
    • Abstract: The length of exclusivity periods is the only major difference between pending US House and Senate bills, both largely based...      Related Stories
      More Biosimilars Of Herceptin And Remicade Get EMA Yes
      Clovis Confident, Portola Not: CHMP Decides On EU Marketing Applications
      China Open To Views, Change But Some Gaps Remain 
      PubDate: Thu, 22 Mar 2018 15:49:11 GMT
       
  • CHPA Eyes Spanning Self-Care Space With Bridge To Device Sector
    • Abstract: Many CHPA members also market medical devices "and the consumer side of medical devices is something they feel is underrepresented...      Related Stories
      Nine Months And Counting: Santen Still Waiting For Final Marketing Decision On Drug Fast-Tracked By EMA
      Get Full Regulatory Alignment Or See Post-Brexit Declines In Trials, Manufacturing, Product Launches, Says UK Committee
      Dova Aims For Accelerated Assessment In EU For Avatrombopag 
      PubDate: Tue, 20 Mar 2018 17:00:23 GMT
       
  • Alka-Seltzer Plus Labeling Error Prompts Recall From Some US Stores
    • Abstract: Recall is second in a year for products marketed under the iconic Alka-Seltzer brand. Alka-Seltzer Plus line comprises products indicated...      Related Stories
      Long Serving Deputy Becomes China Health Commissioner
      Keeping Track: A Burst Of Breakthroughs, A Priority Review For Keytruda, And Some Supplemental Submissions
      New MHRA Guideline Could Be Global Pharma?s Go-To Standard For GxP Data Integrity 
      PubDate: Fri, 16 Mar 2018 18:00:23 GMT
       
  • Gottlieb An Anchor For OTC Drug Industry On Stormy Congressional Seas
    • Abstract: Commissioner Gottlieb has been a “very strong champion” of FDA and his interest in improving the OTC monograph and switch...      Related Stories
      Shire, Microsoft and Eurordis Partner To Improve Diagnosis And Treatments For Rare Disease
      Shire, Microsoft and Eurordis Link Up To Improve Diagnosis And Treatments For Rare Disease
      Vibha Test 
      PubDate: Thu, 15 Mar 2018 19:40:39 GMT
       
  • For Successful OTC Switch Proposals, A Good Offense Defends Against
           Doubters
    • Abstract: OTC switch sponsors should identify adversaries early in the application switch process so they can counter arguments that could derail...      Related Stories
      EMA Explores How To Make Therapeutic Indication Wording More Consistent
      US Launch Of Sensipar Generics May Await Patent Case Even After FDA Approval
      New Right To Try Bill Fails To Persuade 
      PubDate: Tue, 13 Mar 2018 17:46:33 GMT
       
  • Firms Spread Diaper Rash, Skin Care Brands, Move Lice Kit License In OTC
           Sector Deals
    • Abstract: Randob Labs agreed to purchase the Balmex brand of baby and adult skin protectants from Moberg Pharma for $4.25m. Mission...      Related Stories
      EMA Explores How To Make Therapeutic Indication Wording More Consistent
      US Launch Of Sensipar Generics May Await Patent Case Even After FDA Approval
      New Right To Try Bill Fails To Persuade 
      PubDate: Mon, 12 Mar 2018 16:17:14 GMT
       
  • Perrigo ANDA Approval Brings New Options To Generic Mucinex DM Maximum
           Strength Portfolio
    • Abstract: Perrigo?s first OTC drug approved in 2018 is extended-relief guaifenesin 1,200 mg and dextromethorphan 60 mg tablets, planned for launch...      Related Stories
      Second EMA Public Hearing To Focus On Quinolone, Fluoroquinolone Side Effects
      Pharma Welcomes UK-Wide Applicability Of Revised Model Clinical Trials Agreement
      Firms To Make Clinical Details More Prominent In Australian Product Information 
      PubDate: Fri, 09 Mar 2018 16:57:22 GMT
       
  • OTC Switches Face Tougher FDA Evaluations, Less Predictable Process
    • Abstract: OTC switch sponsors bear more responsibility than in previous years to convince FDA a product would be safely used and...      Related Stories
      No EMA Membership For UK After Brexit, Says European Council
      Companion Diagnostics In Oncologic Development: Idhifa And Lynparza Show Benefit Of Early Focus
      Same Trial, Different Endpoints: FDA Guided Idhifa To Full Approval By Recasting Clinical Analyses 
      PubDate: Wed, 07 Mar 2018 17:42:06 GMT
       
 
 
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