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Mylan N.V., a global pharmaceutical company, has announced the US launch of moxifloxacin hydrochloride in 0.8% sodium chloride injection, 400 mg/250 mL (1.6 mg/mL) in 250 mL single-dose flexible bags, the first AP-rated generic version of Bayer's Avelox.
The product is being marketed and distributed by Mylan's subsidiary, Mylan Institutional, under a final approval from the US Food and Drug Administration (FDA) for an Abbreviated New Drug Application (ANDA) for this product, which is a fluoroquinolone antibacterial indicated for treating infections in adults caused by designated susceptible bacteria in community acquired pneumonia, skin and skin structure infections, complicated intra-abdominal infections, plague, acute bacterial sinusitis and acute bacterial exacerbation of chronic bronchitis.
Currently, Mylan has 225 ANDAs pending FDA approval, representing approximately $92.5 billion in annual brand sales. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $41.9 billion in annual brand sales, for the 12 months ending July 31, 2017, according to QuintilesIMS. Currently, one out of every 13 prescriptions filled in the US - brand-name or generic - is a Mylan product.
Mylan, generic avelox injection, us market
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