ANDAby

Mahender.K

M.Pharm(pharmacology)

Under the guidance ofDr. S.Y. Manjunath

Srikrupa institute of pharmaceutical sciences

Velkatta,kondapak,medak.

Andhra pradesh.

ABBREVIATED NEW DRUG APPLICATION (ANDA): It is a complete set of documents required to

be submitted as an application for getting approval for a drug as a generic drug or generic version drug of an already approved brand name drug to market and sale generic version of that drug.

Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the public.

GOAL OF ANDA

To reduce the price of the drug.

To reduce the time development.

Increase the bioavailability of the drug in comparison to references list drug.

The generic drug product are almost equally safe, effective and comparable to that of an already available brand name drug with respect to indications of use and performance, route of administration, more importantly their cost too is less compared to brand name drugs

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.

Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug).

BIOEQUILANCE

5

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, or

The extent of absorption does not show a significant difference and any difference in rate is intentional or not medically significant.

Using bioequivalence as the basis for approving generic copies of drug products was established by the "Drug Price Competition and Patent Term Restoration Act of 1984," also known as the Waxman-Hatch Act.

Abbreviated or Supplemental NDA:o Abbreviated NDA: includes.. Generic drug New combination of approved drugs Proportion of ingredients in combination is

changedo Supplemental NDA: includes.. New intended use of the drug (labeling change) Dose, method or duration of administration is

changed Change in manufacturing process or location

ANDA review process:

NDA VS. ANDA REVIEW PROCESS:

Requirements for NDA: Labeling Pharmacology and

toxicology Chemistry Manufacturing Controls Microbiology Inspection Testing Animal studies Human studies Bioavailability

Requirements for ANDA:

Labeling Pharmacology and

toxicology Chemistry Manufacturing Controls Microbiology Inspection Testing Bioequivalence

A pharmaceutical company can also submit ANDA for a drug product electronically as electronic submission is cost effective and takes less time as well.

Once a generic drug or a drug innovated by a pharma company as their brand name drug is approved by US FDA it appears in the list of approved drugs which is also called as ‘orange book’.

FORMAT OF ANDA:

Three copies of application are required, an archival copy, a review copy and a field copy.

FDA will maintain guidance documents on the format and content of applications to assist applicants in their preparation.

Application form Table of contents

FILING OF ANDA:

Within 60 days after FDA receives an application, the agency will determine whether the application may be filed.

The filing of an application means that FDA has made a threshold determination that the application is sufficiently complete to permit a substantive review.

If FDA finds that none of the reasons for refusing to file the application apply, the agency will file the application and notify the applicant in writing.

The date of filing will be the date 60 days after the date FDA received the application. The date of filing begins the 180-day period described in section 505(c) of the act. This 180-day period is called the "filing clock."

FDA will approve an application and issue the applicant an approval letter on the basis of draft labeling if the only deficiencies in the application concern editorial or similar minor deficiencies in the draft labeling.

Such approval will be conditioned upon the applicant incorporating the specified labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed labeling prior to marketing.

APPROVAL OF ANDA:

TIME FRAMES FOR REVIEWING ANDA BY FDA:

Within 180 days of receipt of an application for a new drug under section 505(b) of the act or an abbreviated application for a new drug under section 505(j) of the act, FDA will review it and send the applicant either an approval letter under 314.105 or a complete response letter under 314.110. This 180-day period is called the "initial review cycle."

At any time before approval, an applicant may withdraw an application under 314.65 or an abbreviated application under 314.99 and later submit it again for consideration.

The initial review cycle may be adjusted by mutual agreement between FDA and an applicant or as provided in 314.60 and 314.96, as the result of a major amendment.

RESOURCES FOR ANDA SUBMISSIONS

Guidance Documents for ANDAs Guidance documents represent the Agency's

current thinking on a particular subject. These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products.

They also establish policies intended to achieve consistency in the Agency's regulatory approach and establish inspection and enforcement procedures.

Because guidences are not regulations or laws, they are not enforceable, either through administrative actions or through the courts.  An alternative approach may be used if such an approach satisfies the requirements of the applicable statute, regulations, or both.

LAWS, REGULATIONS, POLICIES AND PROCEDURES

The mission of  FDA is to enforce laws enacted by the U.S. Congress and regulations established by the Agency to protect the consumer's health and safety.

The Federal Food, Drug, and Cosmetic Act is the basic food and drug law of the U.S. With numerous amendments it is the most extensive law of its kind in the world. 

The law is intended to assure consumers that foods are pure and wholesome, safe to eat, and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labeling and packaging is truthful, informative, and not deceptive.

CODE OF FEDERAL REGULATIONS (CFR)

 The final regulations published in the Federal Register (daily published record of proposed rules, final rules, meeting notices, etc.) are collected in the CFR. 

The CFR is divided into 50 titles which represent broad areas subject to Federal regulations. 

The FDA's portion of the CFR interprets the Federal Food, Drug and Cosmetic Act and related statutes.  Section 21 of the CFR contains most of the regulations pertaining to food and drugs.

MaPPs : CDER's Manual of Policies and Procedures

(MaPPs)  provide official instructions for internal practices and procedures followed by CDER staff to help standardize the drug review process and other activities, both internal and external.  

MaPPs define external activities as well.  All MAPPs are available for the public to review to get a better understanding of office policies, definitions, staff responsibilities  and procedures. 

Amendments to an unapproved ANDA: An applicant may amend an abbreviated new drug application

that is submitted, but not yet approved, to revise existing information or provide additional information.

Amendments containing bioequivalence studies must contain reports of all bioequivalence studies conducted by the applicant on the same drug product formulation, unless the information has previously been submitted to FDA in the abbreviated new drug application.

If a summary report of a bioequivalence study is submitted and FDA determines that there may be bioequivalence issues or concerns with the product, FDA may require that the applicant submit a complete report of the bioequivalence study to FDA.

Submission of an amendment containing significant data or information before the end of the initial review cycle constitutes an agreement between FDA and the applicant to extend the initial review cycle only for the time necessary to review the significant data or information and for no more than 180 days.

NDA ANDA

Applicable for new drug Applicable for generic drug

Take longer time ( 12-15 years)

Compare to NAD less time taken(1-2 years)

More expenditure of money Comparatively less

Cost of drugs are more Cost of drugs are less

Nonclinical studies and clinical investigations are essential

Nonclinical studies and clinical investigations are nonessential except bioavailability and bioequivalence

REFERENCES:

http://www.fda.gov/cder/guidance/index.htm. http://www.fda.gov/drugs/

developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/abbreviatednewdrugapplicationandagenerics/default.htm

http://www1.pointcross.com/source/ddg/charts/andachart.htm

http://www.accessdata.fda.gov/scriptHYPERLINK "http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.94"sHYPERLINK "http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.94"/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.94

 

Thank you