Abbreviated New Drug Applications (ANDA)

PRESENTED BY: Ramneet Kaur M.Pharm Pharmaceutics Amity institute of pharmacy

ABBREVIATED NEW DRUG APPLICATIONS (ANDA)1

Contains data submitted to FDA's Center for Drug Evaluation and Research Office of Generic Drugs - Review and final approval for Generic drug Manufacturers of generic drugs receive approval to market an off patent drug in the United States of America Once approved - Generic drug product can be manufactured and marketed

Goals of ANDA1
Tool for

facilitating the approval of a generic drug

To reduce:

Drug price Development time a cost effective manner

Availability in

Market demand increases

ANDA 1
Applicable for generic drug

NDA 2
Applicable for new drug

Compared to NDA less time taken Takes longer time ( 12-15 years) (1-2 years) Bioequivalence studies Nonclinical studies and clinical investigations are essential
More expenditure

Lesser expenditure of money Cost of drugs is less

It is more

Generic Drugs1


Bioequivalent and comparable to a reference listed drug in dosage form, strength, route of administration, identity, purity, quality, performance and intended use Also known as copycat drugs and sold at low price Manufactured under the same strict standards of FDA's Good Manufacturing Practice (GMP) regulations required for innovator products Can be over-the-counter (OTC) drugs or prescription drugs Ibuprofen - Advil ( OTC analgesic ) Fluoxetine - Prozac (prescription drug) Not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness - Termed as Abbreviated

 

Hatch-Waxman Act1
Drug Price Competition and Patent Term Restoration Act - 1984
To

control drug price

Brand-name

companies can apply for up to five additional years patent protection while their products are going through FDA's approval process generic drug manufacturers to "challenge" an existing patent by filing an ANDA prior to expiration of patent bioequivalence as the basis for approving generic drug

Allows

Established

products

DATA BASES FOR FILING AN ANDA

y y y y y y y

Electronic Orange Book Drugs @ FDA NDC (National Drug Code) Directory Dissolution Method Database IIG (Inactive ingredient guide) Database Drug product Bioequivalence database Freedom of Information

Electronic Orange Book3,4

o

Also known as Approved Drug Products with Therapeutic Equivalence Evaluations Managed by FDA Orange colored cover Its list first appeared as a print publication in 1980 Appropriate starting place for : Identification of patents claiming an approved drug Formulations of the approved drug Therapeutic uses of the drug

o Patents are subsequently published in the Orange Book oOrange Book Search added to the FDA website - October 31, 1997 o Can search by active ingredient, proprietary name, applicant, or application number

EXAMPLE
Appl No N011210 TE Code AA RLD Yes Active Ingredient BENZONATATE Dosage Form CAPSULE Route ORAL Strength 100MG Proprietary Name TESSALON Applicant FOREST LABS

N011210

AA

Yes

BENZONATATE

CAPSULE

ORAL

200MG

TESSALON

FOREST LABS

Drugs @ FDA5
y

Contains official information about FDA approved branded, generic drugs and therapeutic biological products Search by - drug name, active ingredient or application number Used to find: - Label information for approved drug products - Generic drug products for a brand name drug product - All drugs with the specific active ingredient - Approval history of a drug

NDC (National Drug Code) Directory6,7

y

Similar to the Bar Coding system Upto 11 digits in length Separated by hyphens (-) into three segments First segment - Labeler code - identify the manufacturer of the drug (4-5 characters) Second segment Product code - identifies the strength, dosage form and formulation (3-4 characters) Third segment - Package code - identifies package size (12character)

Unique product identifier for drugs Appears on all drug labels Searchable database with download facility Drug products are identified and reported using NDC

Dissolution Method Database8

o

Searchable database containing FDA recommended dissolution methods for approved drug products Main challenges for dissolution studies includes: To select a suitable dissolution method for development Profile matching of Test & Innovator in official media for all strengths Select a discriminatory media (by varying media, speed or volume) Matching Innovator dissolution profile in discriminatory media

Has information regarding innovator product: USP dissolution apparatus used Speed of dissolution to be carried out Medium to be taken for carrying out dissolution Recommended sampling times

IIG (Inactive ingredient guide) Database9

Searchable database - available with USFDA Contains information about inactive ingredients used in FDA approved drug products One can vary the inactive ingredients from that of the innovator

Maximum dose/day for a particular excipients can be calculated

Updated quarterly- by tenth working day of April, July, October, and January

Drug product Bioequivalence database10

y

Generic drug product needs to be bioequivalent with the innovator product Contains FDA recommendations for carrying out bioequivalence studies Updated regularly

Freedom of Information11
India - Right to Information y United States - Freedom of information act (FOIA) y Using the FOIA information about Approval letter Package insert Labeling FDA final reviews Summary Basis of Approval (SBOA) for an NDA and ANDA
y

Submission Requirements1
o

Model Bioequivalence Data Summary Tables Developed by - Division of Bioequivalence Purpose - Data can be submitted to the Office of Generic Drugs in a concise format Common Technical Document (CTD) - Set of specification for application dossier for registration of Medicines Quality, Safety and Efficacy Completed tables and Bioequivalence submissions of ANDA are required to be sent

ANDA Filings13
y

Generic manufacturer is required to identify the necessary patent holders affected by the early ANDA filing Identification is set out in the ANDA application itself where the filer chooses between four alternative certifications or paragraphs Described in section 505(j)(2)(A)(vii) of the Act Paragraph I Drug has not been patented Approval effective after OGD scientific determination Paragraph II Patent already expired Approval effective after OGD scientific determination Paragraph III Date on which the patent will expire Tentative approval after OGD determination, final approval when patent expires Paragraph IV Patent Challenge Tentative approval after OGD determination, final approval when challenge won

y y

Paragraph IV certification13
According to section 505(j)(2)(B)(i), 2157 CFR y ANDA applicant must provide appropriate notice of a paragraph IV certification to each owner of the patent and to the holder of the approved NDA to which the ANDA refers And by Section 505(j)(5)(B)(iv) y 180-day period of marketing exclusivity is provided as an incentive for generic manufacturers to file paragraph IV certifications and to challenge listed patents

180-Day Exclusivity Period13

Awarded to first ANDA holder to file a complete application with patent challenge Protection from other generic competition blocks approval of subsequent ANDAs

Guidance Documents for ANDAs1

y y y

Represent the Agency's current thinking on a particular subject Prepared for FDA review staff and applicants Establish policies intended to achieve uniformity in the agency's regulatory approach and to establish inspections These are not regulations or laws and are not enforceable either through administrative actions or through courts

Generics Procedural Draft1

Distributed for comment purposes only Applications Covered by Section 505(b)(2)

Biopharmaceutics1
Bioavailability and Bioequivalence Studies for Drug Products Useful for applicants - planning to conduct bioavailability and bioequivalence studies

Drug Master Files1

Submit to FDA Provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs

MaPPs (Manual of Policies and Procedures)1

Provide official instructions for internal practices and procedures followed by CDER staff Help to standardize the drug review process and other activities (both internal and external) Available for the public to review to get a better understanding of office policies, definitions, staff responsibilities and procedures Help prepare ANDAs Listed together on CDER's Manual of Policies and Procedures webpage Chapter 5200 Explains Generic Drugs

Electronic Submissions 1

ANDA Checklist for Completeness and Acceptability Office of Generic Drugs revised the regulatory filing checklist to enhance the ANDA review process Regulatory filing checklist reviewed on a quarterly basis (calendar year) and updated on an as needed basis Office of Generic Drugs developed a guidance document entitled Providing Regulatory Submissions in Electronic Format To assist applicants making regulatory submissions in electronic format

CDER

Sun Pharma gets USFDA for anti-cough drug12

y

USFDA granted approval to market a generic version of Forest Labs Tessalon Benzonatate capsules Sun Pharmaceutical Industries received marketing approval for the ANDA of its generic version of anti-cough drug Benzonatate Benzonatate capsules available in the market in two strengths of 100mg and 200mg Used to relieve cough due to the common cold, bronchitis, pneumonia and other lung infections

REFERENCES
1.

2.

3. 4. 5. 6. 7.

http://www.fda.gov/drugs/developmentapprovalprocess/howdrugs aredevelopedandapproved/approvalapplications/abbreviatednewd rugapplicationandagenerics/default.htm http://www.fda.gov/drugs/developmentapprovalprocess/howdrugs aredevelopedandapproved/approvalapplications/newdrugapplicati onNDA/default.htm http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm http://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm http://hayajneh.org/g/2010/12/national-drug-code-ndc http://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm

8.http://www.accessdata.fda.gov/scripts/cder/dissolution/disclaimer. cfm 9. http://www.fda.gov/Drugs/InformationOnDrugs/ucm080123.htm 10.http://www.fda.gov/drugs/guidancecomplianceregulatoryinforma tion/guidances/ucm075207.htm 11. http://www.state.gov/m/a/ips 12. http://articles.economictimes.indiatimes.com/2008-0321/news/28421188_1_usfda-nod-100mg-generic-version-2011-08-31 13. Office of Generic Drugs, http://www.fda.gov/cder/ogd

THANK YOU