通过FDA网站查询品牌药是否存在仿制药(来自GPhA)

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1、 1Is My Prescription Available as a Less Expensive Generic? You can use the FDAs online information to find out! The FDA Web site lists all of the prescription medicinesbrand and genericthat have been approved by the FDA. You can begin your search by following these step-by-step instructions. To loc

2、ate the information, type http:/www.accessdata.fda.gov/scripts/cder/drugsatfda/ into the address line of your Web browser (Internet Explorer, Netscape, AOL, for example) and then hit “Enter” on your keyboard. Alternatively, you can type http:/www.fda.gov/cder/ into the address line of your Web brows

3、er. Once youve arrived at this FDA Web site, look at the right hand side of the page for the column titled “Quick Info Links” and click on “DrugsFDA.” You should see the Web page below: There are three easy ways to search for your prescription medicine: by using the brand name, generic name, or view

4、ing the list of drug names. We recommend “browse by drug name.” 2Browsing by Drug Name If you arent sure how to spell a drugs name, whether its the brand or generic name, you can look it up by clicking on a letter of the alphabet, located in the center of the page under “Browse by Drug Name.” EXAMPL

5、E: Suppose you were searching for the brand name “Zocor” (generic name: simvastatin). Use your mouse to click on the letter Z. 3After youve clicked on a letter, youll see a page listing all of the approved drugs that have names beginning with that letter. This list, arranged in alphabetical order, i

6、ncludes both brand and generic names. Scroll down the page until you see the name of the drug for which you are searching. There might be more than one page of names. In that case, youll see the word “Page” with a number next to it located on the right-hand side of the page. Click on the name of the

7、 drug (it should be underlined) to view more information. EXAMPLE: Scroll down the page until you see the name “Zocor,” then click on it to view more information about the medicine. 4Clicking on the name of the drug will take you to this next page, which provides an overview of the drug. This page l

8、ists the active ingredients, manufacturer, strength and dosage forms (tablet, capsule, etc.) of the drug. However, the important point is to determine whether a generic is available. Next, to find out whether there is a generic version, look at the table that appears under the words “Click on a drug

9、 name or application number to view drug details.” You will see a heading on the left side of this table titled, “Drug Name and FDA Application Number.” Look below this heading. You will see the name of the drug for which you are searching in the yellow part of the table. (In this EXAMPLE, you would

10、 see Zocor (NDA#019766).) If you know the strength and dosage form of the drug for which you are searching, you can check to see if the information in the table matches what you are looking for. Sometimes the FDA has approved a generic version of one form of the drug but not another. This informatio

11、n will be listed on the same line as the drug name. Now that youve checked the table, click on the name of the drug that appears in the yellow box of the table. The name should be underlined and appear with a number. In this EXAMPLE, you would click on “Zocor (NDA#019766).” 5After youve clicked on t

12、he name of the drug, a page titled “Drug Details” should appear. If a generic is available, it will tell you in two different places on this page. The first way is to check the table located in the lower part of the page titled “Products on Application.” In this table, look at the last column on the

13、 right, “TE Code.” This refers to “Therapeutic Equivalence,” or generic version. If you look in that column and see the letters “AB” listed next to the name, active ingredient, dosage form and strength of the prescription medicine that you use, then a generic version is available. You might also see

14、 other “A” codes (AA, AN, AO, AP and AT) listed in that column. All of these codes mean that the generic is available and may be substituted for the brand. If there is no code listed next to the name of your prescription medicine, then the generic version is not yet available. You might also see a c

15、ode that begins with “B” (e.g., BX), which means that the products are not equivalent and not substitutable for the brand product. The second way to determine whether a generic is available is to look for the words “Therapeutic Equivalents,” which should appear in the center of the page. If no gener

16、ic is available, then you will see the words “There are no Therapeutic Equivalents” on the page. 6Click on “Therapeutic Equivalents” to view the list of generic drugs that may be substituted for the brand. In the above EXAMPLE for Zocor, you can see “AB” and “Therapeutic Equivalents” on the page. That means a generic version is available. On this “Therapeutic Equivalents” page, youll see a listing of all of the gener

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