Mylan’s Indian subsidiary Matrix Laboratories has received US Food and Drug Administration (FDA) approval for its Lansoprazole delayed-release capsules.
They are a generic version of Tap Pharmaceuticals’ Prevacid proton pump inhibitor capsules, which had US sales of $3 billion for the 12 months ending June 30.
Mylan reportedly has 125 abbreviated new drug applications (ANDAs) pending approval, which represent $84 billion in annual brand sales. Of these, 37 are potential first-to-file applications worth $19 billion a year.
Mylan is a world-ranking generic pharmaceutical company selling into 140 countries and territories. It has one of the industry’s broadest product portfolios and is the third-largest drug manufacturer, including respiratory and allergy treatments.
Copyright Press Association 2009