Watson announced that it has launched Clarithromycin Extended-Release Tablets, USP in the 500 mg strength. Watson's Clarithromycin Extended-Release product is the generic equivalent to Abbott's Biaxin(R) XL, which is indicated to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. For the 12-months ending September 2007, Biaxin(R) XL and its generic equivalents had total U.S. sales of approximately $200 million, according to IMS Health data.
The U.S. Food and Drug Administration granted final approval of Watson's Abbreviated New Drug Application (ANDA) for Clarithromycin Extended-Release on June 24, 2004. Patent infringement litigation related to Watson's ANDA was dismissed with prejudice on July 12, 2007.
The U.S. Food and Drug Administration granted final approval of Watson's Abbreviated New Drug Application (ANDA) for Clarithromycin Extended-Release on June 24, 2004. Patent infringement litigation related to Watson's ANDA was dismissed with prejudice on July 12, 2007.
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