PHARMACY

FDA to take ‘tailored policy’ to mobile medical app regulation

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration will not enforce regulatory requirements for most mobile medical apps because they "post minimal risk to consumers," the agency said Monday.

The FDA announced the issuance of guidance on the apps, saying it would adopt a "tailored policy" toward regulation, focusing its regulatory oversight on those apps that present greater risk if they do not work as intended.

"Some mobile apps carry minimal risks to consumers or patients, but others can carry significant risks if they do not operate correctly," FDA Center for Devices and Radiological Health director Jeffrey Shuren said. "The FDA’s tailored policy protects patients while encouraging innovation."

As examples, the FDA cited apps that can allow doctors to diagnose patients with potentially life-threatening conditions outside traditional healthcare settings, as well as helping consumers manage health and wellness, including some that can diagnose abnormal heart rhythms, allow smartphones to function as mobile ultrasound devices or function as the "central command" for a diabetic patient’s glucose meter.

As such, the FDA said it would focus on apps that are intended for use as accessories for regulated medical devices or that transform smartphones and other mobile devices into medical devices. Mobile apps subject to FDA review would undergo the same regulatory processes as other medical devices.

"We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly," Shuren said. "Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products."

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PHARMACY

FDA approves Perrigo angina pectoris drug

BY Alaric DeArment

ALLEGAN, Mich. — The Food and Drug Administration has approved a drug made by Perrigo Co. for treating heart disease, the company said Monday.

The FDA approved Perrigo’s nitroglycerin lingual spray in the 400-mcg-per-spray strength. The drug is used to relieve attacks of or prevent angina pectoris due to coronary artery disease.

The drug is a generic version of Arbor Pharmaceuticals’ Nitrolingual Pumpspray, which has sales of about $65 million, according to Perrigo. As the first company to win approval for the generic version, Perrigo has 180 days in which to compete exclusively against Arbor.

 

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Teva launches generic niacin extended-release tablets

BY Alaric DeArment

JERUSALEM — Teva Pharmaceutical Industries has launched a generic drug for treating cardiovascular disease, the company said.

Teva announced the launch of niacin extended-release tablets in the 500-mg, 750-mg and 1,000-mg strengths. As the first company to file for approval of the drug, Teva will have 180 days in which to market the generic version exclusively.

The drug is a generic version of AbbVie’s Niaspan, used to treat elevated low-density lipoprotein or "bad" cholesterol, triglycerides and other lipids in the blood. Niaspan had sales of about $1.12 billion during the 12 months ended in June, according to IMS Health.


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