Mylan Inc., a global pharmaceutical company, has announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the US 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 generalised 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.
Phenytoin chewable tablets USP, 50 mg, had US sales of approximately $16.5 million for the 12 months ending September 30, 2012, according to IMS Health. Mylan is shipping this product immediately.
Currently, Mylan has 185 ANDAs pending FDA approval representing $80.6 billion in annual sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $21.2 billion in annual brand sales, for the 12 months ending June 30, 2012, according to IMS Health.