Abbrevated New Drug Applications- Basics
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The document discusses Abbreviated New Drug Applications (ANDAs), which are applications for generic drug approval submitted to the FDA. Key points: - ANDAs are used to gain approval for generic versions of off-patent drugs without requiring costly preclinical and clinical testing, as long as they are proven to be bioequivalent to the branded version. - The Hatch-Waxman Act of 1984 established the modern ANDA pathway, allowing generics to reference pioneer drug data and challenging patents to bring cheaper drugs to market sooner. - ANDAs must demonstrate the generic drug is identical to the branded reference drug in active ingredients, strength, dosage form, route of administration, quality and labeling. Bioequival
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Abbrevated New Drug Applications- Basics
- 1. 10/11/2014 1 ANIRBAN SAHA AMITY INSTITUTE OF PHARMACY M.Pharm (Pharmaceutics) Semester-1 Enrollment No: A10647014005
- 2. Abbreviated New Drug Application (ANDA) It is an application for generic versions of Off-Patent Drugs to receive FDA approval with less cost or no preclinical and clinical testing. 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). 10/11/2014 2
- 3. Safety and effectiveness of the drug in its proposed use The methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity . To reduce the price of the drug. To reduce the time for development. Drug's proposed labeling is appropriate. 10/11/2014 3
- 4. 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. 10/11/2014 4
- 5. Necessary Items of ANDA •The composition of 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, 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. 10/11/2014 5
- 6. In 1970 FDA established the ANDA as a mechanism for the review and approval of generic versions. During 1970-1983, generic product applicants were required to submit complete safety and efficacy through clinical trials. Neither of these approaches was considered satisfactory and so originated Hatch Waxman Act on 1984. Orrin Grant Hatch Henry Arnold Waxman 10/11/2014 6
- 7. Commonly known as “Drug Price Competition & Patent Term Restoration Act” of 1984. “The Hatch-Waxman Act” is an act dealing with the approval of generic drugs and associated conditions for getting their approval from FDA, patent term extension and Orange Book Listing.” It is because of this Act that there is the availability of less costly generic drugs into the market without conducting costly and duplicative clinical trials. At the same time, the brand-name companies (innovators) can apply for upto five additional years longer patent protection for the new medicines that they developed to make up the time lost while their products were going through FDA's approval process. 10/11/2014 7
- 8. Same active ingredients. Same route of administration. Same dosage form. Same strength. Same conditions of use other active and inactive ingredients already approved in a similar NDA. 10/11/2014 8
- 10. 10/11/2014 10
- 11. Guidance documents to help prepare ANDAs are listed together in the following categories: Biopharmaceutics: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations .This guidance should be useful for applicants planning to conduct bioavailability (BA) and bioequivalence (BE) studies intended for submission in an ANDA . Drug Master Files: A Drug Master File (DMF) is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. 10/11/2014 11
- 12. Application form Table of contents Reference and test drugs Conditions of use Active ingredients Route of administration, dosage form and strength. Bioequivalence review Labeling Data regarding Samples: need not be submitted until requested by FDA. Patent certification Financial certification or disclosure statement. Chemistry, manufacturing and controls 10/11/2014 12
- 13. 10/11/2014 13
- 14. Amoxil (NDA APPLICANT DR.REDDY’S) GENERIC DRUG MANUFACTURER AUROBINDO PHARMA APPROVED ON NOV 9TH ,2005 Ultracet (NDA APPLICANT JANSSEN PHARMS) GENERIC DRUG MANUFACTURER MYLAN LABS APPROVED ON SEPTEMBER 26TH ,2008. ACCUPRIL(NDA APPLICANT PFIZER) GENERIC DRUG MANUFACTURER AUROBINDO PHARMA Approved ON APRIL 29th ,2013. EXELON(NDA APPLICANT NOVARTIS)GENERIC DRUG MANUFACTURER DR.REDDY’S APPROVED ON OCTOBER 31,2007. 10/11/2014 14
- 15. http://www.fda.gov www.fda.gov/AboutFDA/CentersOffices/.../C DER http://www.fda.gov/OGD Generic Drug Product Development Solid Oral Dosage Forms By Leon Shargel & Isadore Kanfer 10/11/2014 15
- 16. 10/11/2014 16
Editor's Notes
- #2: ANDA PAGE NO 1