Bayshore Granted Expedited Review for Recent ANDA Submission

Bayshore Pharmaceuticals is pleased to announce the acknowledgment from U.S. FDA of “expedited review” status for its most recent Abbreviated New Drug Application (“ANDA”) submission. “This acknowledgment from FDA of expedited review status for our recent ANDA submission is yet another milestone for Bayshore and represents our continued success in following the strategic plan we developed for our Product Portfolio Selection Process last year. We are especially excited to be adding this product to our portfolio because not only may we be the sole generic player in the market, but there is a significant U.S. Government business opportunity we are targeting as well,” says Mark Moshier, President of Bayshore.