Lupin's levofloxacin 250mg, 500mg and 750mg tablets are the AB-rated generic equivalent of Levaquin, a synthetic broad spectrum antibacterial agent used to treat or prevent infections that are proved or strongly suspected to be caused by susceptible bacteria.
The Indian company is prominent among Indian generic players that are looking to benefit from the increasing penetration of generic drugs in the U.S. and Japan--two of the world's largest pharmaceutical markets by sales. The U.S. will see several top-selling drugs lose patent protection over the next several years, while Japan's government has been pushing to raise generic products usage in the country for some time now.
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.
The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.
A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, and route of administration, quality, performance characteristics and intended use.