What is 505(b) (2) application?
A 505 (b)(2) application is an NDA containing full reports of safety and effectiveness investigations. Here some of the information required for the approval comes from the studies conducted by or for the applicant. For this, the applicant might not obtain a right of reference or use. NDAS requires full reports of investigations of safety and effectiveness that were conducted by or for the applicant, for which the applicant has a right of reference or use, also known as stand-alone NDA s. these are submitted under section 505 (b) (1) of the FD and C act.
More about ANDA:
An ANDA is an application submitted and approved under section 505(j) of the FD &/C act for a drug product that is a duplicate of an earlier known approved drug product. This relies on FDA’s findings that the previously approved drug product is safe as well as effective. It also ensures that clinical investigations are necessary to establish the safety and effectiveness of the proposed product.
An ANDA generally must cover all information to show that the proposed generic product is the same as the RLD concerning the dynamic ingredient(s), conditions of use, route of management, dosage form, asset, and labelling (with certain allowable changes) and is bioequivalent to the RLD.
Below are the considerations for the submission of ANDAS and 505b2 FDA applications include the following situations:
1. Drug product is a duplicate of the RLD: FDA tends to refuse to file applications for the drug if its already listed and is eligible for approval as an ANDA.
2. Drug product is not similar to RLD: A candidate may defer to a fitness petition to FDA requesting consent to submit an ANDA for a generic drug product that varies from an RLD in its way of administration, amount form, or strength.
3. Other drug products contain the same ingredients: An applicant may pursue approval for numerous drug products covering the same active ingredient(s) when some of these products would succeed for support under the section 505(j) pathway, and some would qualify for support under the 505b2 FDA pathway. In this case, the candidate may bundle these drug products by submitting a single 505(b)(2) application.
The above information is about 505(b) (2) applications that the FDA covers. Food and drug administration is one of the major topics to be talked about. And one should know about the applications being passed and approved to be prevented from being a part of any scam.