FDA approves Mylan's generic Dilantin chewable tablets
PITTSBURGH — Mylan on Friday announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its phenytoin chewable tablets USP in the 50 mg strength.
The product is a generic version of Pfizer's Dilantin Chewable Tablets, which are indicated for the control of generalized tonic-clonic (i.e., grand mal) and complex partial (i.e., psychomotor, temporal lobe) seizures, and prevention and treatment of seizures occurring during or following neurosurgery.
Phenytoin chewable tablets USP 50 mg, had U.S. sales of approximately $16.5 million for the 12 months ending Sept. 30, 2012, according to IMS Health. Mylan is shipping this new product immediately.
Currently, Mylan has 185 Abbreviated New Drug Applications 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.