An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.

A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. All approved products, both innovator and generic, are listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).

Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy, volunteers. This gives them the rate of absorption, or bioavailability, of the generic drug, which they can then compare to that of the innovator drug. The generic version must deliver the same amount of active ingredients into a patient’s bloodstream in the same amount of time as the innovator drug.

Using bioequivalence as the basis for approving generic copies of drug products was established by the “Drug Price Competition and Patent Term Restoration Act of 1984,” also known as the Waxman-Hatch Act. This Act expedites the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of brand-name drugs without conducting costly and duplicative clinical trials. At the same time, the brand-name companies can apply for up to five additional years longer patent protection for the new medicines they developed to make up for time lost while their products were going through FDA’s approval process. Brand-name drugs are subject to the same bioequivalence tests as generics upon reformulation. For more information on generic drug bioequivalency requirements, please see the chapter entitled “FDA Ensures Equivalence of Generic Drugs” in “From Test Tube to Patient: Improving Health Through Human Drugs.”

The Office of Generic Drugs home page provides additional information to generic drug developers, including an interactive flowchart presentation of the ANDA review process, focusing on how CDER determines the safety and bioequivalence of generic drug products prior to approval for marketing. Generic drug application reviewers focus on bioequivalence data, chemistry and microbiology data, requests for plant inspection, and drug labeling information.

Women who are or who may become pregnant must not handle crushed or broken Propecia tablets. The medication could be absorbed through the skin. Propecia is known to cause birth defects in a developing male baby. Exposure to whole tablets should be avoided whenever possible, however exposure to whole tablets is not expected to be harmful as long as the tablets are not swallowed.

The generic drug approval process has evolved over the past 30 years. In 1970 FDA established the Abbreviated New Drug Application (ANDA) as a mechanism for the review and approval of generic versions of drug products that had been approved between 1938 and 1962.[8] For drugs approved after 1962, manufacturers of generic products were required to submit complete safety and efficacy data. Until 1978 manufacturers conducted clinical efficacy and safety trials. After 1978, however, manufacturers were required to cite published reports of such trials documenting safety and efficacy. Neither of these approaches was considered satisfactory, as the former was quite expensive and the latter required evidence that was usually unavailable, i.e., data that had not been published. In 1984 the Drug Price Competition and Patent Term Restoration Act focused on modifying and accelerating the ANDA procedure and gave FDA statutory authority to approve generic versions of innovator products approved after 1962 as safe and effective.[8-10]

Unlike the New Drug Application (NDA) process, by which new chemical entities are approved for marketing, the ANDA process as revised in 1984 does not require manufacturers to include preclinical or clinical data establishing the active ingredient’s safety and efficacy[8] because these data were previously documented during the approval process for the innovator product. Because the generic product must be pharmaceutically equivalent and bioequivalent to the innovator product, it is expected that the two products will also be therapeutically equivalent. In other words, the assumption is that if the active ingredient has been shown to be safe and effective after it is absorbed into the bloodstream, any product that gives rise to the same concentrations of active ingredient in the body to the same rate and extent will produce the same effect; therefore, preclinical and clinical studies of the generic product are usually deemed unnecessary. FDA classifies products as therapeutically equivalent if they:

• Have been shown to be safe and effective.
• Are bioequivalent in that there is no known or potential bioequivalence problem and the products meet acceptable in vitro standards or, if the products do present a potential or demonstrated bioequivalence problem, they meet appropriate bioequivalence requirements.
• Have similar potential for safety and efficacy.
• Are appropriately labeled.
• Are manufactured in compliance with Current Good Manufacturing Practice guidelines

MOBIC is a nonsteroidal anti-inflammatory drug (NSAID) indicated to help relieve the signs and symptoms of osteoarthritis and rheumatoid arthritis. MOBIC is available in 7.5 mg and 15 mg once-daily tablets. Doses higher than 15 mg per day should not be taken due to an increased risk of serious stomach and intestinal problems.

• You should not take MOBIC if you have had an allergic-type reaction to meloxicam, aspirin or other NSAIDs. MOBIC should not be taken if you have asthma. MOBIC cannot be taken in the place of aspirin and is not intended to help prevent a heart attack or stroke.
• NSAIDs may increase the chance of a heart attack or stroke, which may occur without warning and could result in death. They should never be taken right before or after heart surgery.
• NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms.
• NSAIDs may cause serious life-threatening skin reactions. If you develop a rash, discontinue the medication immediately and call your doctor.
• NSAIDs can cause fluid retention (swelling). Contact your doctor if you experience an unexplained weight gain or any swelling.
• Pregnant women should consult with their physicians before taking MOBIC. However, MOBIC should not be taken by women in late pregnancy.
• Tell your doctor if you have advanced kidney disease or any symptoms suggesting liver problems.
• In clinical trials, the most common side effects were diarrhea, indigestion, headache, and flu-like symptoms. Tell your doctor if you experience any unusual symptoms.

• Zithromax is in a group of drugs called macrolide antibiotics. Zithromax fights bacteria in the body.
• Zithromax is used to treat many different types of infections caused by bacteria, such as respiratory infections, skin infections, ear infections, and sexually transmitted diseases.
• Zithromax may also be used for purposes other than those listed in this medication guide.