Healthcare Industry News: U.S. Food and Drug Administration
News Release - December 4, 2018
Mylan Expands Gastroenterology Portfolio with Launch of Generic for Prevacid(R) SoluTab Delayed-Release Orally Disintegrating TabletsMylan's Lansoprazole Delayed-Release Orally Disintegrating Tablets are approved to treat certain types of gastrointestinal ulcers
HERTFORDSHIRE, England and PITTSBURGH, Dec. 4, 2018 -- (Healthcare Sales & Marketing Network) -- Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced the U.S. launch of Lansoprazole Delayed-Release (DR) Orally Disintegrating Tablets (ODT), 15 mg and 30 mg, a generic version of Takeda's Prevacid® SoluTab DR ODT. Mylan Pharmaceuticals received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which has the same indications as the reference listed drug, including treatment of active ulcers of the stomach and small intestine, gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome. The introduction of Lansoprazole DR ODT bolsters Mylan's gastroenterology portfolio, which is one of the company's major therapeutic areas, and further drives access for patients.
U.S. sales for Lansoprazole DR ODT, 15 mg and 30 mg, were approximately $168 million for the 12 months ending September 30, 2018, according to IQVIA.
Currently, Mylan has 168 ANDAs pending FDA approval representing approximately $85.9 billion in annual brand sales, according to IQVIA. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $50.3 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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