An abbreviated new drug application (ANDA) contains information submitted to the FDA for examination and possible approval of a generic drug product. Once approved, an application may produce and promote the generic drug product as a safe, effective, and less expensive alternative to the brand-name drug it references. It must prove that a proposed generic medicine is equivalent to an existing approved reference-listed drug (RLD) in terms of safety, efficacy, and quality. The Hatch-Waxman Act of 1984 established the ANDA process, which amends the Federal Food, Drug, and Cosmetic Act to facilitate the approval of generic pharmaceuticals. An ANDA is a request to the Food and Medication Administration (FDA) to produce and commercialize a generic medication in the United States. It enables the applicant to refer to the safety and efficacy data of an already approved medicine. This approach helps to make safe and effective generic medications more affordable to the general people. The ANDA does not mandate that the applicant undergo clinical studies. An ANDA-approved medicine must be biologically identical to the brand-name drug.
An ANDA includes the new drug's established name, trade name (if any), chemical name, dosage form(s), strength(s), method of administration, and intended use. The ANDA requests the name of the listed drug product, to which the proposed generic is equivalent. The ANDA also specifies whether the drug will be available over the counter or with a prescription. The application may be requested to submit additional data on medication chemistry, production and controls, and other technical information. If an ANDA is granted, the generic drug will be included in the Orange Book, a list of all medicines that the FDA has determined to be safe, effective, and low-cost alternatives for the public. An ANDA includes the information required by the FDA to assess a proposed generic drug's safety and efficacy in comparison to its brand-name equivalent. The FDA will not approve a generic unless it is both safe and effective.
The stages involved in filing an Abbreviated New Drug Application (ANDA) for FDA approval are as follows:
Pre-ANDA Preparation: During this step, the sponsor should collect information on the reference listed drug, such as its chemical and pharmacological qualities, formulation, labeling, and regulatory history. This information determines if the generic medicine is identical to the reference-listed drug.
Preparation of the ANDA: The sponsor creates the ANDA, which includes information on the chemical, pharmacological, and clinical aspects of the generic medication. This information demonstrates that the generic medicine is similar to the reference mentioned drug. The ANDA also includes details about the production process, quality control, and proposed labeling.
Submission of the ANDA: Once completed, the sponsor sends it to the FDA's Center for Drug Evaluation and Research (CDER). You must submit the ANDA electronically using the FDA's electronic submissions channel.
FDA Review: The FDA evaluates the ANDA to ensure it meets the requirements for approval. The review process generally takes about 30 months, but the FDA can speed it up for medications that cure serious illnesses or meet unmet medical needs.
FDA Decision: After reviewing the ANDA, the FDA will either approve or deny it. If approved, the sponsor may begin marketing the generic medication.
The time required for each step of the ANDA process varies according to the drug's complexity and the availability of information. Pre-ANDA and ANDA preparation can take several months to a year, while the FDA review procedure takes approximately 30 months.