PHARMACY

Inomax’s market exclusivity gets extended

BY Alaric DeArment

CLINTON, N.J. — The Food and Drug Administration has extended by six months the market exclusivity of a lung disease drug for use in children.

Drug maker Ikaria said Wednesday that the FDA had extended pediatric exclusivity period for the drug Inomax (nitric oxide) from January 2013 to July 2013.

Ikaria said the extension was based on results of a clinical study of the drug in preterm infants with bronchopulmonary dysplasia, a serious condition that results from lung injury.

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Report: Sharfstein to leave FDA

BY Alaric DeArment

SILVER SPRING, Md. — Food and Drug Administration principal deputy commissioner Joshua Sharfstein will leave the agency to become head of the Maryland Department of Health and Mental Hygiene, according to published reports.

The Washington Post reported Wednesday that Sharfstein, the FDA’s top official after commissioner Margaret Hamburg, had received an invitation to head the state health department from Gov. Martin O’Malley.

Before assuming his position at the FDA, Sharfstein served as head of the Baltimore City Health Department.

It was in that capacity that Sharfstein filed a Citizen’s Petition to restrict the recommendation of pediatric cough-cold medicines to children older than age 6 years. More recently, Sharfstein stood alongside Council for Responsible Nutrition president and CEO Steve Mister and other supplement industry representatives in announcing a crack-down on those Internet companies distributing adulterated pharmaceutical products marketed as dietary supplements.

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FDA to require ‘substantially equivalent’ reviews of new tobacco products

BY Alaric DeArment

SILVER SPRING, Md. — Certain tobacco products introduced to the market or changed after Feb. 15, 2007, are subject to enhanced scrutiny by the Food and Drug Administration, the agency said Wednesday.

The FDA said it would require the companies making the products — ranging from roll-your-own tobacco to smokeless tobacco products — to prove they are “substantially equivalent” to those on the market on or before that date in order to keep them on the market — meaning they must be the same in terms of ingredients, design, composition, heating source and other characteristics. The new policy was adopted under the FDA’s authority to regulate tobacco products, mandated by the Family Smoking Prevention and Tobacco Control Act of 2009.

“This specific part of the law is meant to ensure that new tobacco products are evaluated by the FDA before they are cleared to enter the marketplace,” FDA Center for Tobacco Products director Lawrence Deyton said. “The law requires [the] FDA to carefully examine the impact those products may have on the public health.”

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