Abbreviated New Drug Application (ANDA) Details

The request for an abbreviated new drug application (ANDA) does not require any clinical trials, making them easier to review when compared to New Drug Applications on name-brand drugs. If the FDA approves the application, an ANDA applicant whose product provides a more effective, safer, or lower costing alternative to an original brand can then proceed with its manufacture, marketing, and distribution.

The ANDA drugs must be compatible with the branded innovator product in:

  • Strength and quality,
  • Dosage form,
  • Route of administration,
  • Performance characteristics, and
  • Intended use.

The bioequivalent generic drug gets tested against the brand-named product for relief, dosages, and time to effectiveness qualities by the FDA's Center for Drug Evaluation and Research, Office of Generic Drugs. All the products that the FDA has approved through ANDA are listed in its Orange Book or Approved Drug Products with Therapeutic Equivalence Evaluations.

Real-World Example of an Abbreviated New Drug Application

GlaxoSmithKline LLC recently filed an ANDA for an oral suspension with the proprietary name of Mepron, whose active ingredient is Atovaquone. This generic solution has a 750 mg or 5 ml strength according to the FDA's Database of Drug Approvals.

Approval of the generic drug isn't guaranteed by the filing of an ANDA, as this can only be possible if the original manufacturer's patent protection has or is about to expire. Generic drug makers can affect their products' share price to rise with news of an ANDA filing, essentially causing a downturn in the brand-name manufacturer's share price.

Significance of an Abbreviated New Drug Application

In an ANDA, establishing bioequivalence with the brand name drug is the main focus of the FDA's approval. The Hatch-Waxman Act, or the Drug Price Competition and Patent Term Restoration Act of 1984, is a law that allows less costly generic drugs to get expedited approval.

There are no duplicative clinical trials, which take up time and money for generic products. Reformulated brand-named drugs, however, undergo similar bioequivalence tests against their original counterparts. Your ANDA must consider whether the brand-name drug manufacturer has patent protection in place, which allows them to recoup the time spent on the FDA's approval schedule.

Generic drug product ANDAs must also substantiate whether the drug is available on a prescription or over-the-counter basis, particularly if it treats a rare condition. The statistical analysis performed on your drug by the FDA shouldn't find any significant differences with the branded product, except for biological drug generics or biosimilars.

Types of Abbreviated New Drug Applications

To obtain approval for marketing a generic drug product, you must have precise, concise data that meets and is consistent with the regulatory milestones needed. For your ANDA to remain on the FDA's schedule, the request must well establish your drug's chemical composition, intended use, marketing name, and means or route of administration.

The FDA next checks the generic product for contraindications, allergies, and prescription methodologies for which drug chemistry, manufacturing controls, and similar technical data must get provided. There shouldn't be a significant difference between your generic drug and the brand-name product, while any active or inactive ingredients must be FDA approved.

A winning ANDA may be seeking to lower the drug price and reduce the time within which it's developed. Compared to the referenced drug, your generic product could also be higher in bioavailability or increase uptake time for distribution in the patient's bloodstream.

History of Abbreviated New Drug Application

The US's primary food and drug law is the Federal Food, Drug, and Cosmetic Act, intended to address the safety, effectiveness, and wholesomeness of approved drugs and food products. Section 505 of the FD&C Act covers the approval of new brand-name drugs similar but differ in critical ways with approved drugs and generic drugs.

Instead of performing a total efficiency and safe collection of studies for non-novel drugs, ANDA applicants use abbreviated FDA pathways intended to encourage a quicker-to-market time. Charged with regulating and enforcing the FD&C Act, the FDA, among other measures, ensures that;

  1. Foodstuff production is in sanitary conditions with appropriate ingredients.
  2. Drugs and devices are effective, safe, and transparent about side effects.
  3. Cosmetics get manufactured from wholesome ingredients and packaged with truthful, helpful labeling.

Since innovator or original brand name products, especially drugs, are expensive, generic manufactures seek to offer low-cost alternatives within equal therapeutic capacities. The Drug Price Competition and Patent Term Restoration Act of 1984 is an amendment that mandates the FDA to approve market generic after testing them for safety and efficacy.