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Find New Drug Approvals (NDA) and Abbreviated New Drug Applications (ANDA) Issued in a Particular Year for a Specific Company by the FDA?
TOPIC: An ANDA (Abbreviated New Drug Application) is a required application that must be sent to the Federal Drug Administration (FDA) in order to market a product in the U.S. An ANDA must be submitted for the generic version of the brand name drug providing the FDA how your generic version is similar to the brand name of a drug.
A NDA (New Drug Application) is a required application that must be sent to the FDA in order to market a product in the U.S. A NDA is required for all new drug products (never sold in the U.S. previously) that you want to market. The NDA application is required to provide the FDA with all the pre-clinical and clinical data regarding the safety and efficiency of the product, as well as all the manufacturing processes.
Summaries of drug approval for prescription and generic drugs appear about every two weeks and are covered by FDAnews (File 182), which is a good file for current awareness since it updates daily. Approval contains the applicant, ingredients of the drug, the drug name (lab code) and indications. It also includes both ANDA and NDA approvals and type of approval. Some may be tentative approvals and will list the reason for the caution. Additionally, other articles are also included for drugs where there may be a problem (e.g., “Teva Wins Tentative Approval…”).
In this example, you will look for ANDA and NDA drug approvals issued by the FDA for the pharmaceutical company Teva in 2005.
COMMAND SUMMARY
BEGIN 182
SELECT DRUG()APPROVAL?/TI,DE OR ANDA/TI,DE
SELECT S1 and PY=2005
SELECT S2 AND TEVA/TI,CO
Click S3 > Tasks > Picklist
Check records > select format
Click Links > Display > Type Full Record
HOW TO...
1. BEGIN 182 to find drug approvals and applications.
2. SELECT keywords narrowed to the title and descriptors.
3. Limit to the time period for the approvals.
4. If you want approvals for a specific company, narrow to the company name limited to title (/TI) and company name (/CO) fields.
5. In the Set Links pane, click S3 > Tasks > Picklist to see the first 10 records in SHORT format (title and descriptors).
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6. Click the check box(es) for the records you want to see in more detail, select the Output/Format and click Output.
Note that every two weeks a record is listed as “Drug Approvals,” which covers the previous two weeks.
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Prescription and generic drugs are included in the drug approvals.
The text provides the applicant, drug ingredients, drug name, type of approval and indications. |
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It includes both ANDA and NDA approvals and type of approval. Some may be tentative approvals and will list the reason for the caution.
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RELATED HOW DO I...? SOLUTIONS
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