Mylan has reported that its privately held Indian subsidiary, Matrix Laboratories, has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Lansoprazole delayed-release (DR) capsules, 15mg and 30mg.
Lansoprazole capsules are the generic version of Tap Pharmaceuticals’ proton pump inhibitor Prevacid capsules.The company said that the product is shipping immediately and is expected to be sold under the Mylan brand.
Lansoprazole delayed-release capsules is used for treating rheumatoid arthritis, osteoarthritis, or ankylosing spondylitis in patients with a history of gastric ulcer.
The medicine is a combination package that contains an NSAID and a proton pump inhibitor (PPI). It may block certain substances in the body that are linked to inflammation. NSAIDs treat symptoms of pain and inflammation. The PPI works by decreasing the amount of acid produced in the stomach. This decreases the risk of developing an ulcer from using an NSAID.
Mylan has 125 ANDAs pending FDA approval, 37 of these pending ANDAs are potential first-to-file opportunities.