ANDA stands for Abbreviated New Drug Application. The ANDA submission is known to contains Chemistry, Manufacturing and Control information along with bio-equivalence data . The main purpose of the ANDA submission to the FDA is to review as well as ensure potential approval of generic drug the FDA. Once the drug or product receives approval, the applicant is given the freedom to manufacture as well as market the generic drug. The marketing of the specific drug product is aimed at providing a safe, cost-effective, and an effective alternative to the brand-name drug that has been referenced by the company.
A generic drug or product is regarded as the one that can be compared to some innovator drug or product in different aspects including strength, drug dosage, a form of dosage, quality, administration route, intended use, and performance characteristics. All the approved drug products –including both generic as well as innovator drug products, are listed in the Approved Drug Products category of the Therapeutic Equivalence Evaluations by the FDA –also referred to as the “Orange Book.”
Generic Drug Applications for ANDA Submissions to the FDA
The applications of the generic drugs that are given approval by the FDA are referred to as “abbreviated” as they are typically not required to be included in the clinical (human) and preclinical (animal) data for establishing the overall safety as well as effectiveness. On the other hand, applicants of the generic drug products are required to scientifically demonstrate that the respective product performs in a similar manner like that of the innovator drugs. One manner in which the applicants can demonstrate that the particular generic drug product is performing in a similar manner to that of the innovator drug is by measuring the total time it would take the generic drug to approach the bloodstream in some of the healthy participants.
The particular demonstration of “bioequivalence” is known to deliver the overall bioavailability or rate of absorption of the given generic drug product. The demonstration or the results can be then compared to the innovator drug later on. In order to receive approval from the FDA, the generic drug product is required to deliver a similar amount of active ingredients in the bloodstream of the patient –just like the innovator drug.
The ANDA filing preparation starts from the product development stage, it is important that applicant should choose correct RLD and RS for development and BE study purpose. Also, for ophthalmic and injection products it is important that applicant should obtain Q1/Q2 clearance for the proposed formula.
There are several factors which applicant should consider while developing the product or at the manufacturing stage. Failure to comply with FDA requirements while development or manufacturing stage , may result in the ANDA refuse to file and applicant may have to pay 25 % of the application fee as penalty. An experienced consultant can save your lot of money and time.
In addition to the ANDA submission process by the FDA, the companies that manufacture the generic drug products have gained the capability of challenging the patents in the court before marketing the same in the global markets.BACK