Mylan Inc. has announced that its privately held Indian subsidiary, Matrix Laboratories Limited, has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lansoprazole Delayed-release (DR) Capsules, 15 mg and 30 mg. This product is shipping immediately and will be sold under the Mylan Pharmaceuticals brand. Lansoprazole DR Capsules are the generic version of Tap Pharmaceuticals’ proton pump inhibitor Prevacid® DR Capsules. The brand product had U.S. sales of approximately $3 billion for the 12 months ending June 30, according to IMS Health. Currently, Mylan has 125 ANDAs pending FDA approval representing $84.1 billion in annual brand sales, according to IMS Health. Thirty-seven of these pending ANDAs are potential first-to-file opportunities, representing $19.2 billion in annual brand sales, for the 12 months ending June 30, according to IMS Health.
Related Articles Read More >

The need for a data-driven culture in life sciences: What you don’t know can hurt you

The economics behind the Adderall shortage: Why low prices lead to scarcity
The battle of the bulge: Semaglutide and tirzapatide could be new weight-loss warriors
