Content about SILVER SPRING

SILVER SPRING, Md. — A permanent injunction was granted to the federal government Tuesday against a contract manufacturer and distributor of prescription and over-the-counter products, as well as two of its executives.

SILVER SPRING, Md. — The Food and Drug Administration and drug maker Sanofi-Aventis are warning healthcare professionals and patients about the possibility of severe liver injury in patients taking a Sanofi heart drug.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating pain in cancer patients, the agency said Friday.

The FDA announced the approval of ProStrakan’s Abstral (fentanyl) transmucosal tablets for the management of pain that appears suddenly for short periods and is not alleviated by a patient’s normal pain-management plan, also known as breakthrough pain. The tablets are designed for administration on the soft surfaces of the mouth, including inside the cheek, gums and tongue, as well as the nasal passages or the throat.

SILVER SPRING, Md. — International criminals are posing as Food and Drug Administration special agents and other law enforcement officers in order to extort money from consumers, the FDA warned Friday.

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.

SILVER SPRING, Md. — Drugs for bacterial infections and cancer, and one that could help shape regulations for biosimilars, are featured in the Food and Drug Administration’s annual "Generic Drug Roundup."

The roundup is an annual highlighting of what the agency considers the most significant generic drug approvals.

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.

SILVER SPRING, Md. — As a Food and Drug Administration advisory committee convenes to decide whether or not to approve a new drug for treating obesity, two nonprofit groups centered on the epidemic said more means of addressing it are needed.

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for preventing skeletal injuries in patients whose cancer has spread to the bone.

The FDA announced Friday the approval of Thousand Oaks, Calif.-based biotech company Amgen’s Xgeva (denosumab) for bone metastases.

SILVER SPRING, Md. — A class of alcoholic beverages that rapidly became popular among young people over the last few years is headed for the drain.

The Food and Drug Administration issued warning letters to four manufacturers of beverages that combine high amounts of alcohol and caffeine, effectively issuing a federal ban on the beverages.

SILVER SPRING, Md. The Food and Drug Administration has approved a new treatment for breast cancer, the agency said Monday.

The FDA approved Eisai’s Halaven (eribulin mesylate) for patients with breast cancer that has spread and who have received at least two chemotherapy regimens for the disease in its late stages. More than 200,000 women will be diagnosed this year with breast cancer, and nearly 40,000 will die from it, making it the second leading cause of cancer-related death among women, according to the National Cancer Institute.

SILVER SPRING, Md. The main lobbies for the biotechnology and generic drug industries, and a leading manufacturer of generic drugs, testified Wednesday at a hearing sponsored by the Food and Drug Administration to collect public and industry input on the implementation of the regulatory approval pathway for follow-on biologics included in the healthcare-reform bill.