Par Pharmaceutical Companies, Inc.,a specialty pharmaceutical company, has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for clonidine hydrochloride (HCl) 0.1 mg extended-release (ER) tablets. Par has begun shipping the 0.1 mg strength of the product.

Clonidine HCl ER is the generic version of Concordia’s Kapvay and is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications.

According to IMS Health data, annual US sales of Kapvay are approximately $72 million.

Clonidine hydrochloride extended-release tablets are contraindicated in patients with a known hypersensitivity to clonidine.

Par Pharmaceutical Companies, Inc. is a specialty pharmaceutical company that develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals through its wholly-owned subsidiary’s two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals.