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Purdue Pharma granted priority review designation for abuse-deterrent hydrocodone tablet

BY Michael Johnsen

STAMFORD, Conn. — Purdue Pharma on Tuesday 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). 
 
"This is another milestone in our effort to offer patients and health professionals a portfolio of pain medications with abuse-deterrent technology," stated Mark Timney, president and CEO of Purdue Pharma. "I'm proud of Purdue's leadership in advancing this important area of pharmaceutical innovation for the benefit of public health."
 
"It is imperative to provide healthcare professionals with an array of therapeutic options to ensure chronic pain patients receive individualized care," added Todd Baumgartner, VP regulatory affairs and chief medical officer at Purdue Pharma. "If approved by the FDA, this product will be a valuable therapy for treating chronic pain, and it is also designed to deter misuse and abuse by various routes of administration."  
 
Purdue conducted a series of manipulation and extraction studies and clinical abuse liability studies to evaluate the abuse-deterrent properties of this investigational formulation. The data from these studies were recently presented at the 33rd Annual Scientific Meeting of the American Pain Society. 
 
Hydrocodone combination products are one of the most commonly prescribed opioid analgesics in the United States, the company noted. These products are also the most widely abused (nonmedical use), according to the Substance Abuse and Mental Health Services Administration. Currently available hydrocodone formulations do not incorporate abuse-deterrent technologies, Purdue Pharma stated. 
 

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Centor is the new name for Rexam Prescription Products, company announces

BY Michael Johnsen

PERRYSBURG, Ohio — Rexam Prescription Products on Tuesday is changing its name to Centor, the company announced. 

Centor is one of the world’s largest suppliers of regulatory compliant prescription containers for medication dispensing.
 
"Our name [Centor], evoking primarily the Centaur, the powerful creature of Greek mythology, known for wisdom, healing and honor, also conjures the ideas of center and century, as we have been central to the pharmacy industry for over 100 years," the company stated on its new website, CentorRx.com."Our logo reinforces those ideas. The capital C is a visual translation of the simplicity and strength of our closure systems. The lower case evokes proximity and the orange stands for warmth and health."
 
Centor will continue to operate in its current organizational structure with customer contacts remaining unchanged.  Centor’s business remains unaffected by this transition and customers will not notice any change in the way they do business with Centor moving forward.
 

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Mylan launches generic Micardis tablets

BY Ryan Chavis

PITTSBURGH — Mylan announced the launch of telmisartan tablets USP in 20-mg, 40-mg and 80-mg dosage strengths. The drug is the generic version of Micardis tablets from Boehringer Ingelheim and is used to treat hypertension.

Telmisartan tablets had sales in the United States of $259.2 million for the 12 months ending March 31, 2014, according to data from IMS Health.

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