Regulatory and Washington

WILMINGTON, Del. — The Food and Drug Administration has turned down AstraZeneca’s regulatory approval application for a drug to treat heart disease, the drug maker said.

The agency sent AstraZeneca a complete response letter requesting additional analyses of data from a clinical study of Brilinta (ticagrelor), but did not request additional studies. The drug is designed to treat acute coronary syndromes.

A complete response letter means that the FDA has completed its review of a drug application, but issues remain that preclude final approval.

SILVER SPRING, Md. — Just a few months after a Food and Drug Administration advisory committee recommended limiting the use of a Genentech drug designed to treat breast cancer, the regulatory agency is looking to revoke the approval altogether.

WASHINGTON — The dietary supplement industry’s leading trade associations on Wednesday joined forces with the Food and Drug Administration to support heightened efforts to address public health problems posed by products that are illegally marketed as dietary supplements but contain the same active ingredients as FDA-approved drugs or other ingredients that do not qualify as dietary ingredients.

MORRISTOWN, N.J. — Drug maker Watson Pharmaceuticals said it has filed a regulatory approval application for a generic painkiller, challenging the patent that covers the branded version.

Watson announced Tuesday that it had filed an application with the Food and Drug Administration seeking approval for hydromorphone hydrochloride extended-release tablets in the 8-mg, 12-mg and 16-mg strengths. The drug is a generic version of Mallinckrodt’s Exalgo.

WASHINGTON — Tens of millions of Americans have bought medications online without a prescription, according to a new study.

According to research funded by the Alliance for Save Online Pharmacies and released by The Partnership at DrugFree.org, illegal online pharmacies have sold drugs to 36 million Americans.

SILVER SPRING, Md. — A prescription cough suppressant should be kept in childproof containers because of its candy-like appearance, the Food and Drug Administration warned Tuesday.

Tessalon (benzonatate) is made by Forest Labs and comes in the form of a round, liquid-filled gelatin capsule. The drug is used to relieve cough in patients older than 10 years of age.

WASHINGTON — New York’s state Medicaid program could save $2.2 billion over 10 years by managing Medicaid pharmacy benefits more like private-sector employer plans, state employee plans and Medicare, according to a new study by healthcare policy research firm The Lewin Group.

WASHINGTON — As part of its ongoing efforts to stop “bogus” health claims, the Federal Trade Commission on Monday reached a settlement requiring NBTY to stop making false and unproven claims that their supplements promote healthy brain and eye development in children, the agency announced.

NBTY has agreed to pay $2.1 million to provide refunds to consumers who purchased certain multivitamins in its Disney and Marvel Heroes line.