Par Formulations Private Limited, (formerly Edict Pharmaceuticals Private Limited), an operating subsidiary of Par Pharmaceutical Companies, Inc. has received the US Food and Drug Administration (FDA) approval for labetalol HCl tablets 100 mg, 200 mg & 300 mg, the generic version of Trandate.  Par anticipates the product to be available in August.

Labetalol hydrochloride tablets are indicated in the management of hypertension. Labetalol hydrochloride tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.

Labetalol hydrochloride tablets are contraindicated in bronchial asthma, overt cardiac failure, greater-than-first-degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product.  Beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.

Par Pharmaceutical has acquired Chennai, India-based Edict Pharmaceuticals in February 2012.

Par Pharmaceutical Companies, Inc. is a US-based specialty pharmaceutical company.  Through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals, it develops, manufactures and markets higher-barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals.