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news.Ireland-based pharmaceutical firm Actavis has submitted an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) seeking approval to market Rotigotine Extended-release Transdermal Film, 1mg/24 hr, 2mg/24 hr, 3mg/24hr, 4mg/24 hr, 6mg/24hr, and 8 mg/24 hr.
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The company’s ANDA product is a generic version of UCB’s Neupro, which is designed to treat signs and symptoms of idiopathic Parkinson’s disease and moderate-to-severe primary Restless Legs Syndrome (RLS).
On 21 August 2014, UCB, UCB Manufacturing Ireland, UCB Pharma and LTS Lohmann Therapie-Systeme have filed suit against Actavis’ subsidiaries in the US District Court for the District of Delaware, seeking to prevent the Irish firm from commercializing its ANDA product before 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.