Abbreviated New Drug Submissions (ANDS) and Abbreviated New Drug Applications (ANDA)
The review and ultimate approval of a generic drug product is achieved through the data submitted in an Abbreviated New Drug Submission (ANDS) (Canada) or an Abbreviated New Drug Application (ANDA) (U.S.). Once approved, the generic drug can be manufactured and marketed to provide a safe, effective, low-cost alternative to consumers.
Generic drugs are comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. Pre-clinical and clinical data is not required to establish safety and efficacy of generic drugs, hence the term "abbreviated." Rather, bioequivalency between the innovator drug and the generic drug product must be established.
Our regulatory team can assist in the determination of bioequivalence in conjunction with our in-house laboratory, Diteba, providing the tools necessary for successful ANDSs and ANDAs.
Looking for more information on Abbreviated New Drug Submissions or Abbreviated New Drug Applications? Contact a member of our team today or email us directly at firstname.lastname@example.org. You may also request a customized quote and we will contact you with details within two business days.