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news.Mylan's subsidiary Mylan Pharmaceuticals 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.
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Phenytoin is the generic version of Pfizer’s Dilantin chewable tablets, used to control generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures as well as to prevent and treat seizures occurring during or after neurosurgery.
The chewable tablets had nearly $16.5m sales for the 12 months ending 30 September 2012 in US, according to IMS Health.
Following the approval, the company has also initiated shipping of the tablets.