Mylan Launches Generic Apresoline Injection In U.S. - Quick Facts

(RTTNews) - Pharmaceutical company Mylan N.V. (MYL) announced the U.S. launch of Hydralazine Hydrochloride Injection USP, 20 mg/mL, which is a generic version of Novartis AG's (NVS) Apresoline Injection, 20 mg/mL.

Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application or ANDA 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 about $63.4 million for the 12 months ending March 31, 2016, according to IMS Health.

Mylan noted that the launch of this product adds to the company's 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.