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news.Irish pharmaceutical firm Actavis has submitted an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) seeking approval to market Methylphenidate Hydrochloride for Extended-release Oral Suspension, 5mg/mL.
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The company’s ANDA product is a generic version of Pfizer and Tris Pharma’s Quillivant XR, which is a central nervous system (CNS) stimulant indicated to treat attention deficit hyperactivity disorder (ADHD).
On 15 October 2014, Tris filed suit against Actavis in the US District Court for the District of Delaware seeking to prevent the Irish firm from commercializing its ANDA product prior to the expiration of certain US Patents.
The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of the company’s ANDA for up to 30 months.
The stay is from the date the plaintiffs received notice of Actavis’ ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.