Healthcare Industry News: U.S. Food and Drug Administration
News Release - September 13, 2018
Mylan Adds to Cardiovascular Portfolio With Launch of First Generic of Brevibloc(R) Injection in Single-Dose BagsEsmolol Hydrochloride in Sodium Chloride Injection is used to control heart rate
HERTFORDSHIRE, England and PITTSBURGH, Sept. 13, 2018 -- (Healthcare Sales & Marketing Network) -- Global pharmaceutical company Mylan N.V. (NASDAQ : MYL ) today announced the U.S. launch of Esmolol Hydrochloride in Sodium Chloride Injection, 2,500 mg/250 mL (10 mg/mL) Single-Dose Plastic Bag and 2,000 mg/100 mL (20 mg/mL) Single-Dose Plastic Bag, the first generic version of the reference listed drug, Baxter's Brevibloc®.
Mylan is offering Esmolol Hydrochloride in Sodium Chloride Injection, 2,500 mg/250 mL (10 mg/mL) Single-Dose Plastic Bag and 2,000 mg/100 mL (20 mg/mL) Single-Dose Plastic Bag to its institutional customers after an Abbreviated New Drug Application (ANDA) for the product was approved by the U.S. Food and Drug Administration (FDA). Esmolol Hydrochloride in Sodium Chloride Injection is indicated for the short-term treatment of control of ventricular rate in supraventricular tachycardia including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia and control of perioperative tachycardia and hypertension.
U.S. sales for Esmolol Hydrochloride in Sodium Chloride Injection, 2,500 mg/250 mL (10 mg/mL) Single-Dose Plastic Bag and 2,000 mg/100 mL (20 mg/mL) Single-Dose Plastic Bag were approximately $126 million for the 12 months ending June 30, 2018, according to IQVIA.
Currently, Mylan has 189 ANDAs pending FDA approval representing approximately $91.5 billion in annual brand sales, according to IQVIA. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $50.6 billion in annual brand sales, for the 12 months ending June 30, 2018, according to IQVIA.
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.
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