Determination That CUBICIN (Daptomycin) Powder for Injection, 250 Milligrams/Vial and 500 Milligrams/Vial, and CUBICIN RF (Daptomycin) Powder for Injection, 500 Milligrams/Vial, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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The Food and Drug Administration (FDA or Agency) has determined that CUBICIN (daptomycin) Powder for Injection, 250 milligrams (mg)/vial and 500 mg/vial, and CUBICIN RF (daptomycin) Powder for Injection, 500 mg/vial, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for daptomycin powder for injection, 250 mg/vial and 500 mg/vial, if all other legal and regulatory requirements are met.
Abstract as published in the Federal Register.
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