FDA ANDA Application – Generic/Non-patent Drugs

An Abbreviated New Drug Application (ANDA) contains data which when submitted to U.S.FDA, provides for the review and ultimate approval of a generic drug product. -.) Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent. One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy, volunteers. This gives them the rate of absorption, or bioavailability, of the generic drug, which they can then compare to that of the innovator drug. The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug. The following is a list of FDA's review and approval requirements:

• The same active ingredients as the innovator drug (Inactive ingredients can be changed)
• The same strength, dosage form, and route of administration as the innovator drug
• The same indications as the innovator drug
• Bioequivalence
• The same performance characteristics, strength, purity, and quality
• Compliance with Good Manufacturing Practice (GMP)

Service

• Organizing and reviewing the raw materials and product information
• Organizing and reviewing manufacturing process and control materials
• Organizing and reviewing bioequivalence test materials
• Preparing ANDA package
• Submitting ANDA materials to FDA
• Correspondence with FDA
• Routine maintenance of approved ANDA (Annual report, change report, and notification…)

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