Mylan Pharmaceuticals has received approval from the FDA for its supplemental Abbreviated New Drug Application (ANDA) for Haloperidol Tablets USP, 10mg and 20mg. These strengths are in addition to Mylan’s currently marketed 0.5mg, 1mg, 2mg and 5mg strengths of the product.
Reportedly, Haloperidol tablets are an antipsychotic typically used to reduce the symptoms of schizophrenia and uncontrollable tics and outbursts, associated with Tourette syndrome.
The company has 119 ANDAs pending FDA approval representing $84.7 billion in annual brand sales, said IMS Health. Around 35 of these pending ANDAs are potential first-to-file opportunities, representing $16.6 billion in annual brand sales, according to IMS Health.