U.S. FDA Issues Complete Response Letter For SAPHRIS(TM) (ASENAPINE) In The Acute Treatment Of Both Schizophrenia And ... (Medical News Today)
Schering-Plough Corporation (NYSE: SGP) announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for SAPHRIS(TM) (asenapine) sublingual tablets in the acute treatment of schizophrenia in adults and in the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy.

Aurobindo gets final nod for anti-epilepsy drug (Business Standard India)
Aurobindo Pharma Ltd, a Hyderabad-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients (APIs), has received final approvals from the US Food and Drug Administration (US FDA) for Levetiracetam tablets in 250 mg, 500mg, 750 mg and 1000mg strengths and Levetiracetam oral solution in 100mg/ml form.

Report: FDA Speeding Approvals Of Medical Devices (KOLR - KSFX Ozarks)
The Food and Drug Administration is coming under fire from within over its quick approvals for controversial devices. "The New York Times" is reporting that more than three-thousand medical devices sailed through the easiest level of the approval process in 2007.