Approvable Original New Drug Applications
An approvable letter indicates that FDA is prepared to approve the application upon the satisfaction of conditions specified in the approvable letter. Drug products which are the subject of approvable letters may not be legally marketed until the firm has satisfied the identified deficiencies, as well as any other requirements that may be imposed by FDA, and has been notified in writing that the application has been approved. Further information on approvable NDAs is not subject to Freedom of Information (FOI) release until applications are approved.
Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval
A tentative approval indicates that FDA has given an abbreviated new drug application (ANDA) or 505(b)(2) application provisional approval under the terms of the Drug Price Competition and Patent Term Restoration Act. Such drug products that are the subjects of tentative approvals may not be legally marketed until the market exclusivity and/or patent term of the listed reference drug product has expired. Final approval is also contingent upon conditions and information available to FDA remaining acceptable. When the application receives final approval, the product may be legally marketed. The effective approval date will be listed in this publication and in the ” Approved Drug Products with Therapeutic Equivalence Evaluations” list published by FDA. Additional information on these applications will become available to the public when the applications receive final approval. Notes
FDA classifies investigational new drug applications (INDs) and new drug applications (NDAs) to assign review priority on the basis of the drug’s chemical type and potential benefit:
Chemical Type (CHE)
1. New molecular entity, or NME: An active ingredient that has never been marketed in this country.
2. New derivative: A chemical derived from an active ingredient already marketed (a “parent” drug).
3. New formulation: A new dosage form or new formulation of an active ingredient already on the market.
4. New combination: A drug that contains two or more compounds, the combination of which has not been marketed together in a product.
5. Already marketed drug product but a new manufacturer: A product that duplicates another firm’s already marketed drug product: same active ingredient, formulation, or combination.
6. Already marketed drug product, but a new use: A new use for a drug product already marketed by a different firm.
7. Drug already legally marketed without an approved NDA
1 – First post-1962 applications for products marketed prior to 1938
2 – First applications for DESI-related products first marketed between 1938 and 1962 without NDAs
3 – First applications for DESI-related products first marketed after 1962 without NDAs – The indications can be the same or different from the legally marketed product
Effectiveness Supplement Code Definitions
SE1 A new indication or a significant modification of an existing indication, including removal of a major limitation to use, such as second line status.
SE2 A new dosage regimen, including an increase or decrease in daily dosage, or a change in frequency of administration.
SE3 A new route of administration.
SE4 A comparative efficacy claim naming another drug, including a comparative pharmacokinetic claim.
SE5 A change in sections other than the INDICATIONS AND USAGE section that would significantly alter the patient population to be treated, such as addition of pediatric use and/or dosing information or geriatric use and/or dosing information.
SE6 An Rx-to-OTC switch. Treatment Potential (TP)
P-Priority review drug: A drug that appears to represent an advance over available therapy
S-Standard review drug: A drug that appears to have therapeutic qualities similar to those of an already marketed drug.
Other Designations (may apply simultaneously)
AA AIDS drug: A drug indicated for treating AIDS or other HIV related disease.
E Subpart E drug: A drug developed or evaluated under special procedures for drugs to treat lifethreatening or severely debilitating illnesses. (The name refers to Title 21 of the Code of Federal Regulations, Part 312, Subpart E, which governs this classification. Also see, “The Evolution of U.S. Drug Law,” page 26 of the booklet, FDA Consumer IconFrom Test Tube to Patient: NEW DRUG DEVELOPMENT IN THE UNITED STATES.)
V Designated orphan drug: A drug for which the sponsor received orphan designation under the Orphan Drug Act. Such a sponsor is eligible for tax credits and exclusive marketing rights for the drug.