FDA knocks back King Pharmaceuticals self-injectible epilepsy product

King Pharmaceuticals, Inc. has reported the receipt by its Meridian Technologies subsidiary of a letter from the U.S. Food and Drug Administration advising the Company that its Abbreviated New Drug Application (“ANDA”) regarding King’s diazepam-filled auto-injector therapy for the emergency treatment of status epilepticus and severe recurrent convulsive seizures associated with epilepsy is not approvable.

The FDA raised concerns regarding whether the product, a self-injectible therapy, is appropriate for self-diagnosis and use. King is currently evaluating how best to satisfy the concerns raised by the FDA with the intent of amending or resubmitting the application.