Types of ANDA & FDA Review Process

Types of ANDA & FDA Review Process

 

Through an Abbreviated new drug application (ANDA) process, applicant may get FDA approval for a generic drug without conducting clinical trials if the drug is bioequivalent to the branded (innovator) drug. All generic drugs approved by FDA have the same high quality, strength, purity and stability as brand name drugs.

Types of ANDA:

Para I: A Para I filing for the launch of generic drug is made when the innovator has not made the required information in the Orange book.

Para II: A Para II filing is made when the drug is already off patent.

Para III: A Para III filing is made when the applicant does not have any plans to sell the generic drug until the original drug is off patent.

Para IV: A Para IV filing for the launch of generic drug is made when the applicant believes its product or the use of its product does not infringe on the innovator's patents or where the applicant believes such patents are not valid or enforceable.

  

An ANDA certified under paragraphs I or II is approved immediately after meeting all applicable regulatory and scientific (efficacy, safety and bioequivalence) requirements. This means that the generic drugs manufacturer may get immediate approval for manufacturing the generic versions of the branded drugs upon filing an ANDA if, the patent information on the branded drug has not been filed by the branded drug manufacturer or if the patent for the branded drug has expired. A Para III filing is made when the ANDA applicant does not have any plans to sell the generic drug until the original drug is off patent. In case of Para III the application is processed for approval, however its approval status depends upon the product’s patent expiry. ANDA approval under para III certification is made effective from the date of patent expiration.

 An ANDA applicant filing a paragraph IV certification must notify the proprietor of the patent. The patent holder may bring a patent infringement suit within 45 days of receiving such notification. If the patent owner timely brings a patent infringement charge against the ANDA applicant, then the USFDA suspends the approval of the ANDA until the date of the court’s decision that the listed drug patent is either invalid or not infringed the date on which the listed drug patent expires, if the court finds the listed drug’s patent is infringed; or the date that is 30 months from the date the owner of the listed drug’s patent received notice of the filing of a Paragraph IV certification. (Subject to modification by the court). This means that for 30 months from the date of receipt of notice of Para VI filing, no ANDA can be approved. In other words, once the branded drug company indicates its intent to begin a patent infringement suit against the generic company as a result of the paragraph IV filing, the USFDA is prohibited from approving the drug in question for thirty months or until such time that the patent is found to be invalid or not infringed. If, prior to the expiration of thirty months, the court holds that the patent is invalid or would not be infringed, then the USFDA approves the ANDA when that decision occurs. Conversely, if the court holds that the patent is valid and would be infringed by the product proposed in the ANDA prior to the expiration of thirty months, then the USFDA does not approve the ANDA until the patent expires.

FDA Review Procedure:
Drugs intended for human use are evaluated by FDA’s Center for Drug Evaluation and Research (CDER) to ensure that drugs marketed in the United States are safe and effective. Biological products are evaluated by FDA’s Center for Biologics Evaluation and Research.
1.As a part of the review process FDA will send the application of the applicant to OGD/CDER review team for the approval.
2.If the submitted application is not complete or any deficiencies are identified, then "refuse to file letter" is issued by the OGD/CDER to the applicant.
3.In case the application has found complete without any deficiencies then it's accepted & application is then sent to the internal review team for the identification of Bio-Equivalence, Chemistry/Microbiology, Plant inspection & Labeling review issues.
4.If any pending results are found in the application, Bio-Equivalence deficiency letter, & pending satisfactory results are issued accordingly to the applicant.
5.Once the ANDA submission is complete and acceptable without any further queries, the applicant finally receives FDA approval letter.