Mylan has reported that its subsidiary, Mylan Pharmaceuticals has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Levetiracetam tablets, 1000mg.
Levetiracetam tablets are the generic version of UCB Pharma’s antiepileptic Keppra. This additional strength of Levetiracetam tablets complements Mylan’s already approved and marketed strengths of 250mg, 500mg and 750mg.
Levetiracetam are used for treating partial-onset, myoclonic, or generalised tonic-clonic seizures in patients with epilepsy. It is used in combination with other medicines, said the company.
Levetiracetam tablets are a prescription medicine taken by mouth that are used with other medicines to treat, partial onset seizures in people four years of age and older with epilepsy.
Currently, Mylan has 130 ANDAs pending FDA approval. Over 37 of these pending ANDAs are potential first-to-file opportunities, representing $19.2 billion in annual brand sales, according to IMS.