ANDA -Abbreviated NewDrug Application.pptx

Pharmaceutical Regulatory Science

1. ANDA -Abbreviated New Drug Application Bhagyashree Parande Modern College of Pharmacy[For ladies], moshi , pune

2. An “ abbreviated new drug application ” (ANDA) is an application for a generic drug approval for an existing licensed medication or approved drug. 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. All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). 2

3. DESI: Drug Efficacy Study Implementation. When the DESI program was in progress, the agency estimated that there were between 5-13 products without NDAs that were identical and similar to each of the 13,000 products that held NDAs under the 1938 act These products contain the same active ingredients in the same amount and dosage form, often though they claim some unique characteristics i.e : a different salt or ester, different amount, a different dosage form, or an extra added ingredients . 3

4. Evolution of ANDA: CHF patients who had been treated carefully with a specific dose of digoxin, went out of control upon getting prescriptions refilled. Investigations revealed that digoxin was never subject to an NDA varied from manufacturer to manufacturer not in the quantity of actual drug per tablet, but in the amount of drug released from the tablet into the body. The consequences could be life-threatening. The agency responded with an order that each manufacturer submits an ANDA that included bioavailability studies showing the rate and extent of absorption into the body. The ANDA process and bioequivalence studies permitted the individual generic products to be therapeutically equivalent to the approved brand drug. 4

5. ANDA Generics: An ANDA contains data that when submitted to FDA’s center for drug evaluation and research, office of generic drugs. Provides for the review and ultimate approval of a generic drug product. Once approved an applicant may manufacture and market the generic drug product drug to provide a safe, efficient, low-cost alternative to the public. Generic applicants must scientifically demonstrate that their product is bioequivalence. One way to demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 hrs in a healthy volunteer. 5

6. Why it is abbreviated? The term abbreviated is used in generic drug applications because these applications does not require preclinical and clinical data to establish safety and efficacy Scientific demonstration of the bioequivalence is important and must 6

7. Necessary items of ANDA The composition of the drug stating the name and amount of each ingredient whether active or not, contained in a stated quantity of the drug. Identify the place where the drug is manufactured, processed, packaged, and labeled and the name of the supplier of the active ingredient. Identify any person other than the applicant who performs a part of those operations. 7

8. Include certifications from the applicant and the methods used in the process and the facilities and controls used for mfg, processing, packing, and labeling in conformity with the current GMP. Assure that the drug dosage form and components comply with the specifications and tests described in an official compendium. If the drug differs from the compendium drug, the specifications, and tests applied to the drug and its components are adequate to assure their identity, strength, quality, and quantity. 8

9. Outline the methods used in and the facility and control used for mfg, processing, and packaging of the drug. If the drug requires only an ANDA also specify that there must be included adequate data to assure the bioavailability of the drug. 9

10. Goal of ANDA: To reduce the price of the drug. To reduce the time of development. Increase the bioavailability of the drug in comparison to reference list drug. 10

11. WAXMAN- HATCH ACT: Using the bioequivalence as the basis for approving generic copies of products was established by the “drug price commission and patent term restoration act of 1984”, is known as the Waxman-hatch act. This act expedites the availability of less costly generic drugs by permitting FDA to approve an application to market generic versions of brand names without conducting costly clinical trials. Also it provides a mechanism to grant drug companies up to 5 years of additional patent protection to compensate for the patent life lost as a result of the time consumed during tests required by FDA. 11

12. Conditions that must be fulfilled in order to ask for an extension are : Patent must not have expired at the time of filing the request for extension. The product must have been subjected to examination by FDA The request for an extension must have been filed within 60days of the granting of FDA The request for an extension must have been filed at the latest during the last three months of the life of the patent.  A fee of $750 is paid. 12

13. NDA requirements  Labelling Pharm / tox Chemistry Manufacturing Controls Microbiology Inspection Testing Animal studies Clinical studies Bioavailability ANDA requirements Labelling Pharm / tox Chemistry Manufacturing Controls Microbiology Inspection Testing Bioequivalence 13

14. Labeling: Same information as brand name labeling May differ in excipients and product description (color, shapes) Pharm / tox :  All inactive ingredients must be approved in either the reference list or similar NDA in same or higher level 14

15. Chemistry, manufacturing and controls: Components and composition Mfg and controls Batch formulation and records Description of facilities Packaging Stability Microbiology: Includes for anti-infective drug compounds.  A complete description of the biochemical basis of drug action on microbial physiology. Clinical microbiology laboratory methods.  Assure the sterility of products especially with injectables . 15

16. Inspection/testing :  Assure mfg facilities are in compliance with current GMP’S. Assure bioequivalence sites are in compliance with good clinical practices ( cGCP’S ). Bioequivalence:  A generic drug is considered to be bioequivalent to the brand name drug if:-The rate and extent of absorption do not show a significant difference from listed drug. 16

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