Indian pharma sees US FDA norms on ANDA labeling can prevent false labelling issues

Bengaluru, February 1, 2022:

Indian pharma sees that the US FDA guidance calling for ANDA (abbreviated new drug application) labelling updates following revision of the RLD labeling can prevent false labeling issues.

In the US, it is the Indian pharma which has received a higher share of new ANDA approvals since April 2020, led by significant manufacturing plant approvals and a strong filing momentum, supported by investments in research & development.

With the regulatory environment to remain stringent in the US, Indian companies will be able to take the advantage of a better pricing outlook arising from supply shortages. Indian pharma will benefit from an improving demand from the US market, as they have garnered 45 per cent of all new ANDA approvals early last year.

The guidance is intended to assist applicants and holders of an abbreviated new drug application in updating their labeling following revisions to the approved labeling of a reference listed drug (RLD). It provides recommendations on identifying RLD labeling updates and submitting ANDA amendments to update the generic drug labeling.

An ANDA is an application submitted and approved for a drug product that is a duplicate of a previously approved product. An ANDA relies on FDA’s finding that the previously approved drug which is the RLD is safe and effective.

Now an ANDA must contain information to show that the proposed generic product is the same as the RLD with regards to the active ingredient, conditions of use, route of administration, dosage form, strength, and labeling with certain permissible differences and its bioequivalent to the RLD.

Generic drug is required to have the same labeling as the RLD, except for changes required because of differences approved under a suitability petition or because the generic drug and the RLD are produced or distributed by different manufacturers.

FDA regulations provide examples of permissible differences in labeling that may result when a proposed generic drug and the RLD are produced or distributed by different manufacturers, including the omission of an indication or other aspect of labeling protected by patent or exclusivity and labeling revisions made to comply with current FDA labeling guidelines said the guidance.

Consistent with the statute, labeling changes for an ANDA must be submitted in electronic format through the Electronic Submissions Gateway. Certain types of submission for certain positron emission tomography drugs are exempted from the Electronic Common Technical Document (eCTD) requirements. ANDA applicants and holders should submit the respective labeling documents in the appropriate modules according to the Comprehensive Table of Contents Headings and Hierarchy. All holders of marketing applications for drug products both new drug applications (NDAs) and ANDAs) have an ongoing obligation to ensure their product labeling is accurate and not false or misleading.

When new information becomes available that causes the 55 labeling to become inaccurate, false, or misleading, the application holder must take steps to update its labeling. PhamaBiz