Mylan N.V., a global pharmaceutical company, announced the US launch of ampicillin and sulbactam for injection USP, 1.5 g/vial (1 g ampicillin as the sodium salt and 0.5 g sulbactam as the sodium salt), and 3 g/vial (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt), and 15 g, pharmacy bulk package, (10 g ampicillin as the sodium salt and 5 g sulbactam as the sodium salt), the generic version of Pfizer's Unasyn.
Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for these products, which are indicated for the treatment of infections due to susceptible strains of designated microorganisms in skin and skin structure infections, intra-abdominal infections and gynaecological infections.
Ampicillin and sulbactam for injection USP, 1.5 g/vial and 3 g/vial and 15 g, pharmacy bulk package, had US sales of approximately $29 million for the 12 months ending June 30, 2015, according to IMS Health. Mylan's launch of this product adds to the company's growing portfolio of more than 145 injectable products available to patients in the US across a broad array of therapeutic categories including oncology, anti-infectives, anaesthesia/pain management and cardiovascular.
Currently, Mylan has 262 ANDAs pending FDA approval representing $99.3 billion in annual brand sales, according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities, representing $33.4 billion in annual brand sales, for the 12 months ending December 31, 2014, according to IMS Health.