Purdue Pharma Granted Priority Review Designation for Abuse-deterrent Hydrocodone Tablet

Posted July 18, 2014

By Michael Johnsen - Published In Drug Store News (edited)

 

STAMFORD, Conn. — Purdue Pharma recently announced that the Food and Drug Administration has granted priority review designation for the company's once-daily, single-entity hydrocodone bitartrate tablet.

 

The investigational pain medication was formulated to incorporate abuse-deterrent properties designed to make the product more difficult to manipulate for the purpose of misuse or abuse by various routes of administration (e.g., chewing, snorting and intravenous injection). 

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PFOA will be at the RBC & ABC's ThoughtSpot
  • Join PFOA staff members at the RBC in Washington DC. PFOA and Cardinal Health will be holding a meeting on Thursday, July 24 at 1:00 pm in Chesapeake #7-8 room at the Gaylord. Our affiliate, AAP, will hold their meeting at 4:00 pm on Friday, July 25 followed by a social in the Woodrow Wilson Ballroom.

 

  • Join PFOA staff members at ABC’s Thoughtspot July 30-August 2 at the MGM in Las Vegas. Look for us on the trade show floor. Please join us at PFOA’s Friday night Social, August 1st, 6:00 – 8:00 pm, Room 107.
 
FDA slaps Glaxo with warning letter for FluLaval plant

Published on FierceVaccines (http://www.fiercevaccines.com)

June 24, 2014 | By Carly Helfand

Influenza FluLaval Vial
After an inspection from March 31 to April 9 of this year, the FDA didn't much like what it saw at GlaxoSmithKline's ($GSK) Ste-Foy plant in Quebec, home of the company's FluLaval influenza vaccines. Now, the agency has issued a warning, pointing its finger at the British drugmaker for not doing its part to avoid contamination.

 

In a warning letter dated June 12 and posed to the FDA's website Tuesday, the regulator highlighted ongoing bacteria problems that have resulted in GSK tossing more than 20% of the lots it has produced this year alone.

 

And while Glaxo has already responded three times to the FDA's observations, it hasn't yet done enough to ease its worries, the agency said. Now, it wants a rundown of the additional steps the pharma giant will take to correct its manufacturing issues, as well as a meeting with the company.

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Ann Benyo Joins PFOA Staff

Ann Benyo - PFOA Sales Consultant Northeast Region

PFOA is pleased to announce the addition of Ann Benyo to our sales staff. Based in Nazareth, PA, Ann will be visiting PFOA members as well as prospecting for new members in the Northeast area.

 

Ann has extensive experience as a Sales and Marketing Heathcare professional and prides herself on her customer service skills.  During her tenure with SmithKline Beecham, Ann worked as an Executive Sales Consultant, bringing her underperforming territory to one of the top 5 territories in the region. She won several sales awards during her eight years with the company.

 

Ann also has experience in the wholesale drug industry as a Customer Marketing Consultant for Bergen Brunswig Drug Company (now known as AmerisourceBergen).

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Important Cost of Dispensing Survey Needed By July 9

From NCPA, June 24, 2014

 

The Coalition for Community Pharmacy Action (CCPA) is sponsoring a national community pharmacy cost of dispensing study.  CCPA is an alliance between the National Association of Chain Drug Stores (NACDS) and the National Community Pharmacists Association (NCPA) and has contracted with the MPI Group, an independent survey organization, to conduct this survey.  The last study was conducted in 2006.

 

Medicaid's movement toward an acquisition cost system of reimbursement, and CMS' public posting of a final National Average Drug Acquisition Cost (NADAC) file, make the timing of this survey critical and we need your help in responding to the survey.  If you are an owner or manager of a community pharmacy, please complete the questionnaire by July 9 at www.2014CostofDispensing.com.

 

If you are answering for multiple pharmacies, a spreadsheet questionnaire is available by sending an email request to This e-mail address is being protected from spambots. You need JavaScript enabled to view it . You can also download a Word version of the survey and mail it to Cost of Dispensing Study, P.O. Box 4330, Dublin, OH 43016 or fax it to 614-389-3816.  Please do not send your responses to NCPA.

 
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