US-based specialty pharmaceutical firm Par Pharmaceutical has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for clonidine hydrochloride (HCl) extended-release (ER) tablets, the generic version of Concordia's Kapvay.
The company has also started the shipment of Clonidine HCl ER tablets, which are available in 0.1mg strength.
The tablets are intended for treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications.
According to data secured from IMS Health, annual US sales of Kapvay are about $72m.
The company said that Clonidine HCl ER tablets are contraindicated in patients with a known hypersensitivity to clonidine.
Par Pharmaceutical Companies via its two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals, develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals.
