Mylan Unveils Generic Unasyn For Injection - Quick Facts

(RTTNews) - Generic drugmaker Mylan N.V. (MYL) announced the U.S. launch of Ampicillin and Sulbactam for Injection USP, 1.5 g/vial, and 3 g/vial, and 15 g, Pharmacy Bulk Package, the generic version of Pfizer's Unasyn.

Mylan said it received final approval from the U.S. Food and Drug Administration or FDA for its Abbreviated New Drug Application or 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 gynecological infections.

Ampicillin and Sulbactam for Injection USP, 1.5 g/vial and 3 g/vial and 15 g, Pharmacy Bulk Package, had U.S. sales of about $29 million for the 12 months ending June 30, 2015, according to IMS Health.

Mylan stated that the launch of this product adds to the company's growing portfolio of more than 145 injectable products available to patients in the U.S. across a broad array of therapeutic categories including oncology, anti-infectives, anesthesia/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.