However, final approval is subject to the resolution of pending patent litigation after Procter & Gamble sued Teva last year over patent infringement of the drug.
If Teva is granted a firm go-ahead from the FDA, it can begin to participate in a market for the drug thought to be worth approximately $942 million.
A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. New drug applications for generic drugs are termed “abbreviated” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.