Bayshore Pharmaceuticals has announced that the U.S. Food & Drug Administration (FDA) has granted final approval for their Abbreviated New Drug Application (ANDA) for Methscopolamine Bromide tablets (2.5 & 5mg tablets). Methscopolamine Br is available by prescription only and indicated for adjunctive therapy for the treatment of peptic ulcers. The product is the generic equivalent of Fougera’s 2.5 mg Pamine® and 5 mg Pamine Forte®
“Needless to say, the first ANDA approval for any generic pharmaceutical company is a milestone event and Bayshore is thrilled to have achieved this accomplishment. We are now focusing on preparing for its commercial launch and fulfilling the expectations and requirements of our customers” says Mark Moshier, President of Bayshore.