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FDA, Amarin reach settlement on off-label use promotion

BY David Salazar
NEW YORK — Amarin announced Wednesday that New York’s Southern District Court had approved its proposed settlement with the Food and Drug Administration, reached Tuesday, over the promotion of off-label use for its Vascepa (icosapent ethyl) capsules. 
 
The settlement terms allow Amarin to promote off-label use for Vascepa, as long as it is truthful and non-misleading. A judge in August declared that the FDA would limit the company’s first amendment rights if it prevented Amarin from sharing with physicians truthful data that supports a use the FDA hasn’t approved.
 
“We are pleased to announce this amicable resolution with and among the physician plaintiffs, FDA and the U.S. government and look forward to continuing to promote Vascepa in a truthful, non-misleading and responsible manner,” Amarin president and CEO John Thero said. “With more truthful and non-misleading information readily available to healthcare professionals about the potential of Vascepa to improve cardiovascular health, this settlement serves the public interest by supporting informed medical decisions for tens of millions of patients with persistent high triglycerides.”
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Teva launches new generic Pulmicort Respules dosage strength

BY David Salazar
JERUSALEM — Teva on Wednesday announced the U.S. launch of the 1-mg/2-ml dosage strength of its generic Pulmicort Respules (budesonide inhalation suspension). 
 
With the launch, the company completes its portfolio of Pulmicort Respules generics, having previously launched it in strengths of 0.25/2 ml and 0.5 mg/2 ml. The drug is indicated to control and prevent asthma symptoms in children aged 1 to 8 year. 
 
Pulmicort Respules saw U.S. sales of $217 million for the 12 months ended November 2015, according to IMS Health. 
 
 
 
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Diplomat rolls out campaign for MS Awareness Week

BY David Salazar

FLINT, Mich. — Diplomat pharmacy, in honor of Multiple Sclerosis Awareness Week, has rolled out a new campaign featuring patients living with MS. As part of the campaign, the company released a video of one MS patients, highlighting the story of one of the 350,000 to 500,000 people diagnosed with MS. 

"The real-life story of Bethany reveals the true spirit of the Diplomat Difference and the critical role that specialty pharmacy plays in managing some of the nation's most complex patient cases," Diplomat CEO and chairman Phil Hagerman said "At Diplomat, we're committed to not only provide high-touch care through our specially designed programs, but also listen to patient stories and share their victories, whether they be large or small.”
 

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