May 5, 2016 1 min read

CANONSBURG – Mylan N.V. Thursday announced the U.S. launch of Hydralazine Hydrochloride Injection USP, the generic version of Novartis’ Apresoline Injection.

Southpointe-based Mylan said it received final approval from the U.S. Food and Drug Administration for this product, which is used for the treatment of severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.

Hydralazine Hydrochloride Injection USP, 20 mg/mL, had U.S. sales of approximately $63.4 million for the 12 months ending March 31, according to IMS Health.

Mylan’s launch of the product adds to its growing portfolio of more than 150 injectable products available to patients in the U.S. across a broad array of therapeutic categories including oncology, anti-infectives, anesthesia/pain management and cardiovascular.