Mylan announced that its subsidiary Mylan Pharmaceuticals has received final approval from the FDA for its Abbreviated New Drug Application, or 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 and complex partial seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin Chewable Tablets USP, 50 mg, had U.S. sales of approximately $16.5M for the 12 months ending Sept. 30, according to IMS Health. Mylan is shipping this product immediately. Currently, Mylan has 185 ANDAs pending FDA approval representing $80.6B in annual sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $21.2B in annual brand sales, for the 12 months ending June 30, according to IMS Health.
- Pharmaceuticals & Drug Trials
- IMS Health