Determination That Chirocaine (Levobupivacaine) Injection, 2.5 Milligrams (Base)/Milliliter, 10 Milliliter and 30 Milliliter Vials, 5 Milligrams (Base)/Milliliter, 10 Milliliter and 30 Milliliter Vials and 7.5 Milligrams (Base)/Milliliter, 10 Milliliter and 30 Milliliter Vials, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) has determined that Chirocaine (levobupivacaine) injection, 2.5 milligrams (mg) (base)/milliliter (mL), 10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for levobupivacaine injection, 2.5 milligrams (mg) (base)/milliliter (mL), 10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials, if all other legal and regulatory requirements are met.
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