HERTFORDSHIRE, England and PITTSBURGH — Mylan on Wednesday announced the U.S. launch of its generic version of Nexium (esomeprazole magnesium delayed-release capsules) in 20- and 40-mg dosage strengths.
Mylan received approval from the Food and Drug Administration for its Abbreviated New Drug Application for this product, which is used for the treatment of gastroesophageal reflux disease in adults and children ages 1 and older, the company said.
"Mylan's launch of esomeprazole magnesium delayed-release capsules USP represents our continued commitment to expand access to high quality medicine, and we're pleased to provide patients with another affordable treatment option,” Mylan CEO Heather Bresch said.
Sales of the drgu racked up to $5.2 billion for the 12 months ending June 30, according to IMS Health. Mylan now has 268 ANDAs pending FDA approval, representing $101.3 billion in annual brand sales.