which type of data need to file ANDA submission in USA ?
Answer Posted / navinpatel
The 1984 Hatch-Waxman Act effectively extended the
Abbreviated New Drug Application (ANDA) processes that
existed for to all generic drugs. ANDA is filed for the
approval of Generic drug in US after the expiration of DATA
Exclusivity of innovator.
ANDAs do not contain clinical studies but are required to
contain information establishing bioequivalence to the
originator.
ANDA can be filed using the Para filing as below:
Para 1 – Drug has not been patented
Para 2 - Patent has already expired
Para 3 - Date on which the patent will expire and that the
generic drug will not go on the market until that date passes
Para 4 - Patent is not infringed or is invalid
Content of ANDA in ICH CTD format:
1. Application form
2. Table of contents
3. Basis for abbreviated new drug application submission
4. Conditions of use
5. Active ingredients
6. Route of administration, dosage form, and strength
7. Bioequivalence
8. Labeling
9. Chemistry, manufacturing, and controls
10.Samples
11.Patent information
ANDA submission with Para 4 certification will get 180 days
market exclusivity.
Is This Answer Correct ? | 5 Yes | 0 No |
Post New Answer View All Answers
pls send me last two years solved papers of health & malaria inspector to kumar.santosh087@yahoo.com
What are the filing requirements for ANDA-USA, Europe, Brazil, South Africa, Japan and Emerging Markets
You will be required to interact with patients. Tell us about your previous experience with patients and how did you deal with the experience.
What is difference between Warm and Lukewarm Water as per pharmacopia.
What are your intentions towards the uplift of the hospital.
Can any one tell me that which brand hplc column is used for levetiracetam imp- b test.
Caffeine standard is recommended by the monograph for HPLC wavelength accuracy calibration. It is covered range of 205 to 273 only.If the method have wavelength beyond the range, then how it supports for instrument performance?
why you are become a medical representative
why nitrogen charecter as a inert gas plz identified
Explain difference between sonication and homozinization?
Do you think it is possible to rehabilitate?
What skills have you acquired that would apply to the position of Clinical Data Manager?
What are the regulatory commitments in markets like USA, Canada, Europe, Brazil, South Africa and Japan
Anyone have any idea when to conduct Uniformity of Weight (UOW) and when need to conduct Uniformity of Dosage Units (UOD) or when need both? I read BP it only said if average weight < or = 0.04g then just conduct UOD, no need UOW. Under UOD section, it doesnt say when need to conduct UOD but just said UOD got two type, one is Mass Variation (MV), another is Content Uniformity (CU) and under what conditions to conduct them. For USP, no UOW section, only got UOD section.
WHAT IS MEANING OF DEAIATION WITH EXAMPLE