Determination That BORTEZOMIB (Bortezomib) Solution, 2.5 Milligrams/Milliliter and 3.5 Milligrams/1.4 Milliliter (2.5 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration (FDA, Agency, or we) has determined that BORTEZOMIB (bortezomib) solution, 2.5 milligrams (mg)/ milliliter (mL) and 3.5 mg/1.4 mL (2.5 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for BORTEZOMIB (bortezomib) solution, 2.5 mg/mL and 3.5 mg/1.4 mL (2.5 mg/ mL), if all other legal and regulatory requirements are met.
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