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.
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.
Source:
http://drugdelivery.pharmaceutical-business-review.com/news/us-fda-approves-anda-for-mylans-phenytoin-chewable-tablets-010113
