FDA approves use of Crestor for children
WILMINGTON, Del. The Food and Drug Administration has approved an anti-lipid drug for use in children with a genetic cholesterol disorder.
AstraZeneca announced Friday the FDA’s approval of Crestor (rosuvastatin calcium) in children ages 10 to 17 with heterozygous familial hypercholesterolemia, a genetic disorder that causes high levels of “bad” LDL cholesterol in the blood and increased risk of early cardiovascular disease, when diet therapy has failed.
The drug is already approved for treating high cholesterol in adults, though AstraZeneca conducted a further study of the drug on children with HeFH.
“AstraZeneca is committed to studying the impact of Crestor in various populations with high unmet medical need, including pediatric and adolescent patients,” AstraZeneca executive director clinical development for Crestor Alex Gold said in a statement.
Based on the company’s submission of an approval application for the new use of the drug, the FDA has extended Crestor’s market exclusivity by six months, to July 2016, AstraZeneca said.
Actress Olympia Dukakis, husband to appear in diabetes ads
NEW YORK Passengers in New York taxis and viewers watching CNN at the airport will see actress Olympia Dukakis and her husband, Louis Zorich, talking about diabetes.
The appearance of the two actors won’t be in a movie, but in a public service announcement that’s part of drug maker Novo Nordisk’s “Ask. Screen. Know.” campaign to encourage diabetes awareness among the elderly.
FDA approves generic epilepsy treatment
PITTSBURGH Generic drug maker Mylan has received the Food and Drug Administration’s approval for its version of a drug used to treat epilepsy.
Mylan announced Thursday the approval of its topiramate sprinkle capsules in the 15-mg and 25-mg strengths. The capsules are designed to be opened and sprinkled onto soft food and are a generic version of Johnson & Johnson’s Topamax Sprinkle Capsules.
The branded version of the drug had sales of $58 million for the 12-month period ended June 30, according to IMS Health data.