Enforcement Report - Week of June 17, 2020
Antibiotics SA`s Generic Ampicillin and Sulbactam (Ampicillin sodium;Sulbactam sodium) approved in US for Bacterial Infections
Sagent`s Generic Ampicillin sodium approved in US as an Antibiotic
Mylan N.V. (Nasdaq: MYL) today announced the U.S. 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 U.S. 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 gynecological infections.
Hospira`s Generic Ampicillin Sodium (250 mg, 1 gm) approved in US for Bacterial Infections
SA’s medicine supply crisis
SA running out of penicillin