Mylan Pharma Wins Final FDA Approval for ANDA for Phenytoin Chewable Tablets, 50 mg

Mylan Inc.

today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Phenytoin Chewable Tablets USP, 50 mg. This product is the generic version of Pfizer's Dilantin® Chewable Tablets, which are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments.