FDA News

What is it? A totally implanted brain stimulator intended to suppress symptoms associated with Obsessive Compulsive Disorder (OCD) that are not adequately controlled with medications and/or other therapies. (Approved: 2/19/2009)

Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides.

The FDA announced a Consent Decree of permanent injunction filed March 2, 2009, enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers from making and distributing adulterated and unapproved drugs.

Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken.

The U.S. Food and Drug Administration today announced that a facility owned by India-based Ranbaxy Laboratories falsified data and test results in approved and pending drug applications. The facility, Paonta Sahib, has been under an FDA Import Alert since September 2008.

The U.S. Food and Drug Administration today approved a humanitarian device exemption for the first implantable device that delivers intermittent electrical therapy deep within the brain to suppress the symptoms associated with severe obsessive-compulsive disorder (OCD).

The U.S. Food and Drug Administration today issued a public health advisory concerning three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva (efalizumab). Three of those patients have died. All four patients were treated with the drug for more than three years.

At the request of the U.S. Food and Drug Administration, the U.S. District Court for the District of Minnesota on Feb. 17, 2009, entered an order of permanent injunction against seafood processor Captain's Select Seafood Inc., Minneapolis, Minn., and its co-owners Carolyn M. Young and William J. Young.

Treatment with zonisamide can cause metabolic acidosis in some patients.

The U.S. Food and Drug Administration announced today that California device manufacturer Cardinal Health 303 Inc., formerly known as Alaris Medical Systems Inc., and three of its top executives have signed an amended consent decree to correct violations of current Good Manufacturing Practice (cGMP) requirements in the company's infusion pumps.