Mylan N.V. announced the U.S. launch of Metoprolol Tartrate Tablets USP, 37.5 mg and 75 mg, which is the generic version of Novartis' Lopressor® Tablets. These strengths are the first and only available intermediate dosage strengths between the existing Metoprolol Tartrate Tablets USP strengths of 25 mg, 50 mg and 100 mg. Mylan currently is the only manufacturer that offers Metoprolol Tartrate Tablets in five strengths.
Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Supplemental Abbreviated New Drug Application (ANDA) for its Metoprolol Tartrate Tablets, 37.5 mg and 75 mg, which is indicated for the treatment of hypertension.
Metoprolol Tartrate Tablets 25 mg, 50 mg and 100 mg strengths had U.S. sales of approximately $68.9 million across all manufacturers for the 12 months ending Feb. 29, 2016, according to IMS Health.
Currently, Mylan has 265 ANDAs pending FDA approval representing $110.3 billion in annual brand sales, according to IMS Health. Forty-eight of these pending ANDAs are potential first-to-file opportunities, representing $38.3 billion in annual brand sales, for the 12 months ending Dec. 31, 2015, according to IMS Health.
