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(Bortezomib) Solution, 2.5 Milligrams/Milliliter and 3.5 Milligrams/1.4 Milliliter (2.5 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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that BORTEZOMIB (bortezomib) solution, 2.5 milligrams (mg)/ milliliter (mL) and 3.5 mg/1.4 mL (2.5 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness.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.
Abstract as published in the Federal Register.
See the structure of SPEQ’s reviewed analysis
Explorer members can open three bounded, human-reviewed previews each month. Full relationships, analysis, and implementation implications remain protected.
Sign in free to preview →The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.
View on federalregister.gov →Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.