Tiêu đề 12. ABBREVIATED NEW DRUG APPLICATION.pdf ✅

PHARMD GURU Page 1  An abbreviated new drug application (ANDA) contains data which is submitted to FDA center for drug evaluation and research, the office of a generic drug, provides for the review and ultimate approval of a generic drug product.  Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower-cost alternative to the brand-name drug it references. A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics, and intended use.  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. Generic applicants must scientifically demonstrate that their product is performed in the same manner as the innovator drug.  This demonstration of “bioequivalence” gives the rate of absorption, or bioavailability, of the generic drug, which can then be compared to that of the innovator drug. To be approved by the FDA, 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.  Generic drug reviewers focus on bioequivalence data, chemistry & microbiological data, request for inspection and drug labeling information. ANDA REQUIREMENTS SIGNED FDA FORM 356H:  Name & address of the applicant.  Name of the drug product.  Strength.  Route of administration.  Indications.  Whether the product is Prescription/ OTC. INDEX:  Volume.  Page number, for each item involved. ABBREVIATED NEW DRUG APPLICATION SUBMISSION
PHARMD GURU Page 2 INFORMATION ON THE BASIS FOR WHICH THE ANDA IS BEING SUBMITTED:  Name of the reference drug.  Dosage form  Strength  Any special information with respect to the drug. CONDITION FOR USE:  Indication for use.  Labeling details for the given drug product. A STATEMENT THAT STATES THAT ACTIVE INGREDIENT IS THE SAME AS THAT OF A REFERENCE DRUG: For combination products statement must be shown for both ingredients. ROA, DOSAGE FORM AND STRENGTH: Should include a statement that ROA, Dosage form & Strength are same as that of the reference product. BIOEQUIVALENCE: Mention with evidence that the proposed drug is bioequivalent to listed drug product. LABELING:  Copy of currently approved & proposed labeling of listed & reference drug respectively.  Comparisons of both sets of labeling. CHEMISTRY, MANUFACTURING, AND CONTROLS:  Composition.  Manufacture.  Specifications.  Analytical procedures. HUMAN PHARMACOKINETICS & BIOAVAILABILITY:  Designs.  Dosing procedures.
PHARMD GURU Page 3  Number & frequency of Blood & Urine collection.  The methodology of the assay. SAMPLES:  Sample of drug substances & finished products.  Should be provided in 4 individual units, in sufficient quantities to FDA.  Permits FDA to perform all tests (at least thrice). ANALYTICAL METHODS FOR DRUG SUBSTANCE AND DRUG PRODUCT:  Specifications.  Analytical methods.  Validation methods.  Stability tests.  Manufacturing details. CASE REPORT FORMS AND TABULATIONS: Should be discussed with bioequivalence personnel, prior to ANDA Submission.