ANDA Dossier Filing For Reconstituted Oral Suspension in US Market

Abstract

The United States Food and Drug Administration (USFDA) is a very critically regulated agency wherein the submission and approval of new drugs is done. The data in an ANDA Submission, when provided to the FDA's CDER, Office of Generic Drugs, allows for the evaluation and eventual approval of a generic drug product. Generic medications provide a cost-effective alternative to innovator medications, which can help to lower healthcare costs and increase access to essential medications for patients. Given the increasing demand for generic drugs, there is a clear need for companies to develop and market high-quality, effective generic products, such as reconstituted oral suspensions, in order to meet the needs of patients and healthcare providers. Reconstituted oral suspensions are widely used in the treatment of a variety of conditions, including bacterial infections, allergies, and gastrointestinal disorders. These medications are often preferred over other dosage forms, such as tablets or capsules, because they are easy to administer and can be customized to meet the specific needs of patients. This thesis titled "ANDA Dossier Filing for Reconstituted Oral Suspension in the US Market" provides a comprehensive analysis of the preparation and filing process for Abbreviated New Drug Application (ANDA) dossiers for reconstituted oral suspensions in the US market. The study will focus on the key considerations for developing a successful ANDA filing strategy, including the selection of appropriate reference listed drug (RLD), development of a suitable formulation, characterization of the product's physical and chemical properties, and demonstration of bioequivalence. The research will also examine the impact of recent regulatory changes, such as the introduction of the Quality Overall Summary (QOS) format, on the ANDA filing process. Furthermore, a case study of Erythromycin ethyl succinate has been incorporated to understand the process of dossier preparation using the CTD format.Overall, this thesis provides valuable insights into the complex process of ANDA dossier preparation and filing for reconstituted oral suspensions, which is essential for pharmaceutical companies seeking to enter the US market.