- Mylan N.V. (MYL) announces 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 received final FDA approval for its 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 and Zollinger-Ellison syndrome.
- U.S. sales for Lansoprazole DR ODT, 15 mg and 30 mg, were ~$168M for the year ending September 30, 2018, according to IQVIA.