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New Drug Application for Generic Equivalent of Unasyn Approved by FDA
"The addition of Ampicillin and Sulbactam brings to 17 the number of generic anti-infective products in our portfolio and bolsters our industry leading position for these types of injectable products," said Patrick Soon-Shiong, M.D., chairman and chief executive officer. "Our ability to provide customers with a wide array of anti-infectives enabled us to have GPO contracts in place at launch."
Ampicillin and Sulbactam will be available from APP in 1.5g and 3g single dose vials (SDV). The product is preservative-free and AP rated and each vial will include a bar code and latex-free vial stopper. The approval is the fifth product approval APP has received this year.
Ampicillin and Sulbactam is an injectable antibacterial combination consisting of the seminsynthetic antibiotic ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium. Administered intravenously or intramuscular, Ampicillin and Sulbactam is indicated for the treatment of several skin and skin structure, intra-abdominal and gynecological infections due to susceptible strains of microorganisms.
Source: American Pharmaceutical Partners