logging in or signing up Generic_drugs_safe_&_effective sukeshbhardwaj_dra Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: Embed: Flash iPad Copy Does not support media & animations WordPress Embed Customize Embed URL: Copy Thumbnail: Copy The presentation is successfully added In Your Favorites. Views: 1423 Category: Education License: All Rights Reserved Like it (5) Dislike it (0) Added: November 25, 2008 This Presentation is Public Favorites: 6 Presentation Description this presentation contains the brief disscussion about generic drug filing in US by following ANDA. Comments Posting comment... By: mbpsac (14 month(s) ago) very good ppt on anda .ls sir send to me on dileep.mps@gamil.com.thanking you Saving..... Post Reply Close Saving..... Edit Comment Close By: avsashok (18 month(s) ago) sir, presentation is very good and informative. Kindly send me to my e.commail ashok9333@gmail. Saving..... Post Reply Close Saving..... Edit Comment Close By: xyz4 (27 month(s) ago) sir, presentation is very good and informative. Kindly send me to mu e. mail: lalit_lata@hotmail.com Saving..... Post Reply Close Saving..... Edit Comment Close By: Lhy1973 (48 month(s) ago) Useful, quite good Saving..... Post Reply Close Saving..... Edit Comment Close By: anandakrishnan (48 month(s) ago) Very informative and useful all the level of regulatory personnel Saving..... Post Reply Close Saving..... Edit Comment Close Premium member Presentation Transcript GENERIC DRUGS & THE ABBREVIATED NEW DRUG APPLICATION (ANDA) : 1 GENERIC DRUGS & THE ABBREVIATED NEW DRUG APPLICATION (ANDA) Presented by Sukesh Bhardwaj SECTION: 505(j) OF USFDA ANDA/NDA : 2 ANDA/NDA Abbreviated new drug application is submitted under the USFDA section 505(j) of new drug. While NDA (new drug application) also known as innovator's is filed under section 505(b). Note: ANDA contains data which when submitted to FDA’s CDER, office of generic drugs, provides the information for the review and ultimate approval of a generic drug product. ANDA/AADA(Abbreviated New Drug Application) : 3 ANDA/AADA(Abbreviated New Drug Application) A generic drug product is one that is comparable to an innovator drug product ( also known as the reference listed drug (RLD) product as identified in the FDA’s list of Approved Drug Products with Therapeutic Equivalence Evaluations) in dosage form, strength, route of administration, quality, performance characteristics and intended use. ABBREVIATED NEW DRUG APPLICATION : 4 ABBREVIATED NEW DRUG APPLICATION 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.. It is filed against the approved NDA to USFDA by challenging the patent or after the expiration by go through of four para filing (certifications) Once approved an applicant may manufacture and market the generic drug product provided all issues related to patent protection and exclusivity associated with RLD have been resolved. BACKGROUND INFO : 5 BACKGROUND INFO PRE-HATCH-WAXMAN, generics could enter market only through lengthy & expensive NDA process POST-HATCH-WAXMAN, generics can piggy-back on pioneer drug trials Approx. 60% of US Rx now written for generic products Drug Price Competition & Patent Term Restoration Act of 1984 (Hatch-Waxman Act) : 6 Drug Price Competition & Patent Term Restoration Act of 1984 (Hatch-Waxman Act) Created Abbreviated New Drug Application (ANDA) to expedite availability of: safe & effective, but less expensive, generic versions of approved drugs Cont… : 7 Cont… Gave innovator mfrs restored patent rights to compensate for lengthy FDA review time + non-patent marketing exclusivity for qualifying pioneer drug products HATCH-WAXMAN : 8 HATCH-WAXMAN Protected the generic drug industry by: giving patent protection to non-patent holder to make, use, sell the patented drug during patent term. If activity reasonably related to submission of ANDA Essential Requirements for ANDA : 9 Essential Requirements for ANDA Proposed generic’s active ingredients are already FDA-approved. Nothing has called into Q basis of approval for original NDA. Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations). Comparison Between The Requirements of aNew Drug Application (NDA) and an Abbreviated New Drug Application (ANDA) : 10 Comparison Between The Requirements of aNew Drug Application (NDA) and an Abbreviated New Drug Application (ANDA) An ANDA is submitted to the Office of Generic Drugs and includes supporting data for the review and approval of a generic drug product. ORANGE BOOK : 11 ORANGE BOOK ORANGE BOOK : 12 ORANGE BOOK It is called orange book because its front cover is orange colored. “Orange Book” means the FDA’s publication entitled “Approved Drug Products with Therapeutic Equivalence,” in which the patents claiming a drug product approved through an NDA are listed. It consists of coding system to categorize the therapeutically bioequivalent and pharmaceutically equivalent drugs. ANDA MUST CONTAIN : 13 ANDA MUST CONTAIN Information that proposed generic’s conditions of use previously FDA-approved for safety & efficacy ( k/a. RLD) Proof active ingredients = same as listed drug (innovator drug) 3. Information that generic product (proof) proves same route of administration, dosage & strength as listed drug Proof generic product = bioequivalent to listed drug (cont.) : 14 (cont.) Information regarding generic labeling = same as for approved for listed drug, except . . . Basic technical info required of full NDA. 5. Samples of generic & proposed labeling. 6. BA-BE study reports. 7. Patent certification informing FDA of patent status of listed reference drug. PATENT CERTIFICATION : 15 PATENT CERTIFICATION The applicant or sponsor must submit the certification against filing an ANDA for generic drug. Certification is submitted under the section 505(j)(2). Mainly four types:- For I– 505 (j) 2) (A) ((i) For II– 505 (j) (2) (A) ((ii) For III– 505 (j) (2) (A) ((iii) For IV– 505 (j) (2) (A) ( (iv) Brief idea.. : 16 Brief idea.. PARA I FILING no patent information is available PARA II FILING the patent has expired and listed in the orange book. PARA III FILING the patent will be expired and the applicant will not infringed before its term. PARA IV FILING it includes mainly CHALLENGING OF LISTED PATENT. The applicant hence claims that the patent is INVALID,UNENFORCEABLE, or WILL NOT BE INFRINGED by the manufacture, use, or sale of the generic product. Slide 17: 17 Slide 18: 18 180-DAY EXCLUSIVITY PERIOD : 19 180-DAY EXCLUSIVITY PERIOD “180-day exclusivity” is the grant of 180 days of exclusive marketing to the first generic applicant that files an ANDA containing a paragraph IV certification after either i) first commercial marketing by the first generic applicant, or ii) a decision of a court holding the relevant patents to be invalid or not infringed. “Suitability Petitions” : 20 “Suitability Petitions” May be filed for: different active ingredients, routes of administration, and/or dosage forms & strength Where differences will not affect safety & efficacy of generic product. Slide 21: 21 ANDA REVIEW PROCESS BY FDA ANDA Review Progress : 22 ANDA Review Progress QbR: Quality Based Review Slide 23: 23 Number of Submissions Comparison of Receipts and Approvals of ANDA Applications Fiscal Year Slide 24: 24 Generic Competition : 25 Generic Competition helps keep drug costs down encourages research helps keep insurance premiums down saves consumers $8 to $10 billion yearly FDA Requirements for Brand-Name and Generic Drugs : 26 FDA Requirements for Brand-Name and Generic Drugs FDA Requirements for Brand-Name and Generic Drugs : 27 FDA Requirements for Brand-Name and Generic Drugs . Conclusion : 28 Conclusion At last We can say that generic drugs are:- SAFE AND EFFECTIVE AFFORDABLE EASILY AVAILABLE and USE WITH CONFIDENCE, because generics are of same quality ( must meet the same FDA standardsfor quality ) same safety same strength approved by the FDA as brand products. Slide 29: 29 THANKS FOR YOUR ATTENTION You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.
Generic_drugs_safe_&_effective sukeshbhardwaj_dra Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: Embed: Flash iPad Copy Does not support media & animations WordPress Embed Customize Embed URL: Copy Thumbnail: Copy The presentation is successfully added In Your Favorites. Views: 1423 Category: Education License: All Rights Reserved Like it (5) Dislike it (0) Added: November 25, 2008 This Presentation is Public Favorites: 6 Presentation Description this presentation contains the brief disscussion about generic drug filing in US by following ANDA. Comments Posting comment... By: mbpsac (14 month(s) ago) very good ppt on anda .ls sir send to me on dileep.mps@gamil.com.thanking you Saving..... Post Reply Close Saving..... Edit Comment Close By: avsashok (18 month(s) ago) sir, presentation is very good and informative. Kindly send me to my e.commail ashok9333@gmail. Saving..... Post Reply Close Saving..... Edit Comment Close By: xyz4 (27 month(s) ago) sir, presentation is very good and informative. Kindly send me to mu e. mail: lalit_lata@hotmail.com Saving..... Post Reply Close Saving..... Edit Comment Close By: Lhy1973 (48 month(s) ago) Useful, quite good Saving..... Post Reply Close Saving..... Edit Comment Close By: anandakrishnan (48 month(s) ago) Very informative and useful all the level of regulatory personnel Saving..... Post Reply Close Saving..... Edit Comment Close Premium member Presentation Transcript GENERIC DRUGS & THE ABBREVIATED NEW DRUG APPLICATION (ANDA) : 1 GENERIC DRUGS & THE ABBREVIATED NEW DRUG APPLICATION (ANDA) Presented by Sukesh Bhardwaj SECTION: 505(j) OF USFDA ANDA/NDA : 2 ANDA/NDA Abbreviated new drug application is submitted under the USFDA section 505(j) of new drug. While NDA (new drug application) also known as innovator's is filed under section 505(b). Note: ANDA contains data which when submitted to FDA’s CDER, office of generic drugs, provides the information for the review and ultimate approval of a generic drug product. ANDA/AADA(Abbreviated New Drug Application) : 3 ANDA/AADA(Abbreviated New Drug Application) A generic drug product is one that is comparable to an innovator drug product ( also known as the reference listed drug (RLD) product as identified in the FDA’s list of Approved Drug Products with Therapeutic Equivalence Evaluations) in dosage form, strength, route of administration, quality, performance characteristics and intended use. ABBREVIATED NEW DRUG APPLICATION : 4 ABBREVIATED NEW DRUG APPLICATION 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.. It is filed against the approved NDA to USFDA by challenging the patent or after the expiration by go through of four para filing (certifications) Once approved an applicant may manufacture and market the generic drug product provided all issues related to patent protection and exclusivity associated with RLD have been resolved. BACKGROUND INFO : 5 BACKGROUND INFO PRE-HATCH-WAXMAN, generics could enter market only through lengthy & expensive NDA process POST-HATCH-WAXMAN, generics can piggy-back on pioneer drug trials Approx. 60% of US Rx now written for generic products Drug Price Competition & Patent Term Restoration Act of 1984 (Hatch-Waxman Act) : 6 Drug Price Competition & Patent Term Restoration Act of 1984 (Hatch-Waxman Act) Created Abbreviated New Drug Application (ANDA) to expedite availability of: safe & effective, but less expensive, generic versions of approved drugs Cont… : 7 Cont… Gave innovator mfrs restored patent rights to compensate for lengthy FDA review time + non-patent marketing exclusivity for qualifying pioneer drug products HATCH-WAXMAN : 8 HATCH-WAXMAN Protected the generic drug industry by: giving patent protection to non-patent holder to make, use, sell the patented drug during patent term. If activity reasonably related to submission of ANDA Essential Requirements for ANDA : 9 Essential Requirements for ANDA Proposed generic’s active ingredients are already FDA-approved. Nothing has called into Q basis of approval for original NDA. Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations). Comparison Between The Requirements of aNew Drug Application (NDA) and an Abbreviated New Drug Application (ANDA) : 10 Comparison Between The Requirements of aNew Drug Application (NDA) and an Abbreviated New Drug Application (ANDA) An ANDA is submitted to the Office of Generic Drugs and includes supporting data for the review and approval of a generic drug product. ORANGE BOOK : 11 ORANGE BOOK ORANGE BOOK : 12 ORANGE BOOK It is called orange book because its front cover is orange colored. “Orange Book” means the FDA’s publication entitled “Approved Drug Products with Therapeutic Equivalence,” in which the patents claiming a drug product approved through an NDA are listed. It consists of coding system to categorize the therapeutically bioequivalent and pharmaceutically equivalent drugs. ANDA MUST CONTAIN : 13 ANDA MUST CONTAIN Information that proposed generic’s conditions of use previously FDA-approved for safety & efficacy ( k/a. RLD) Proof active ingredients = same as listed drug (innovator drug) 3. Information that generic product (proof) proves same route of administration, dosage & strength as listed drug Proof generic product = bioequivalent to listed drug (cont.) : 14 (cont.) Information regarding generic labeling = same as for approved for listed drug, except . . . Basic technical info required of full NDA. 5. Samples of generic & proposed labeling. 6. BA-BE study reports. 7. Patent certification informing FDA of patent status of listed reference drug. PATENT CERTIFICATION : 15 PATENT CERTIFICATION The applicant or sponsor must submit the certification against filing an ANDA for generic drug. Certification is submitted under the section 505(j)(2). Mainly four types:- For I– 505 (j) 2) (A) ((i) For II– 505 (j) (2) (A) ((ii) For III– 505 (j) (2) (A) ((iii) For IV– 505 (j) (2) (A) ( (iv) Brief idea.. : 16 Brief idea.. PARA I FILING no patent information is available PARA II FILING the patent has expired and listed in the orange book. PARA III FILING the patent will be expired and the applicant will not infringed before its term. PARA IV FILING it includes mainly CHALLENGING OF LISTED PATENT. The applicant hence claims that the patent is INVALID,UNENFORCEABLE, or WILL NOT BE INFRINGED by the manufacture, use, or sale of the generic product. Slide 17: 17 Slide 18: 18 180-DAY EXCLUSIVITY PERIOD : 19 180-DAY EXCLUSIVITY PERIOD “180-day exclusivity” is the grant of 180 days of exclusive marketing to the first generic applicant that files an ANDA containing a paragraph IV certification after either i) first commercial marketing by the first generic applicant, or ii) a decision of a court holding the relevant patents to be invalid or not infringed. “Suitability Petitions” : 20 “Suitability Petitions” May be filed for: different active ingredients, routes of administration, and/or dosage forms & strength Where differences will not affect safety & efficacy of generic product. Slide 21: 21 ANDA REVIEW PROCESS BY FDA ANDA Review Progress : 22 ANDA Review Progress QbR: Quality Based Review Slide 23: 23 Number of Submissions Comparison of Receipts and Approvals of ANDA Applications Fiscal Year Slide 24: 24 Generic Competition : 25 Generic Competition helps keep drug costs down encourages research helps keep insurance premiums down saves consumers $8 to $10 billion yearly FDA Requirements for Brand-Name and Generic Drugs : 26 FDA Requirements for Brand-Name and Generic Drugs FDA Requirements for Brand-Name and Generic Drugs : 27 FDA Requirements for Brand-Name and Generic Drugs . Conclusion : 28 Conclusion At last We can say that generic drugs are:- SAFE AND EFFECTIVE AFFORDABLE EASILY AVAILABLE and USE WITH CONFIDENCE, because generics are of same quality ( must meet the same FDA standardsfor quality ) same safety same strength approved by the FDA as brand products. Slide 29: 29 THANKS FOR YOUR ATTENTION