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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 and 2006.
COMMAND SUMMARY
BEGIN 182
SELECT DRUG()APPROVAL?/TI,DE OR ANDA/TI,DE
SELECT S1 and PY=2005:2006
SELECT S2 AND TEVA/TI,CO
TYPE s3/6/1-5
TYPE S3/9/1
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. |
?b 182
File 182:FDA News Mar. 2002-2006/Aug 23
(c) 2006 Washington Business Info.
Set Items Description
--- ----- -----------
?SELECT DRUG()APPROVAL?/TI,DE OR ANDA/TI,DE
9222 DRUG/TI,DE
2134 APPROVAL?/TI,DE
1126 DRUG/TI,DE(W)APPROVAL?/TI,DE
313 ANDA/TI,DE
S1 1372 DRUG()APPROVAL?/TI,DE OR ANDA/TI,DE
?SELECT S1 AND PY=2005:2006
1372 S1
15312 PY=2005 : PY=2006
S2 356 S1 AND PY=2005:2006
?SELECT S2 AND TEVA/TI,CO
356 S2
424 TEVA/TI,CO
S3 25 S2 AND TEVA/TI,CO |
5. TYPE a few records in Format 6 to see titles, which often include drug name and company.
|
?T S3/6/1-5
3/6/1
0002425018 I444257F0322C11DBA16783D1F5CF6B09 (USE FORMAT 7 FOR FULLTEXT)
Teva Launches Generic Zoloft With Exclusivity
Tuesday, August 22, 2006
WORD COUNT: 419
3/6/2
0002372050 I02589AD0088711DB97A3DD5CDD2A4FDB (USE FORMAT 7 FOR FULLTEXT)
Teva , Roxane Labs Receive FDA Approval to Market Generic Zoloft
Friday, June 30, 2006
WORD COUNT: 262
3/6/3
0002361025 I7CF83A80FFE411DAAA5AEDEFD29AEC9C (USE FORMAT 7 FOR FULLTEXT)
Teva Gets First Approval for Generic Proscar Tablets
Monday, June 19, 2006
WORD COUNT: 148
3/6/4
0002329016 I9E6FCCC0E6BF11DA9104D858DCDE8A98 (USE FORMAT 7 FOR FULLTEXT)
Drug Approvals
Thursday, May 18, 2006
WORD COUNT: 232
3/6/5
0002313009 I4AFE1A70DA1B11DAA508E735DED1D42F (USE FORMAT 7 FOR FULLTEXT)
FDA Approves Teva 's Pravachol After Court Dissolves Stay on Approvals
Tuesday, May 2, 2006 WORD COUNT: 414 |
6. TYPE the record(s) of choice using Format 9 for the complete record.
Note: A portion of the record has been omitted from this display. |
?T S3/9/1
3/9/1
DIALOG(R)File 182:FDA News Mar.
(c) 2006 Washington Business Info. All rts. reserv.
0002425018 I444257F0322C11DBA16783D1F5CF6B09 (THIS IS THE FULLTEXT)
Teva Launches Generic Zoloft With Exclusivity
Generic Line, v23, n16
Tuesday, August 22, 2006
JOURNAL CODE: GELI LANGUAGE: ENGLISH RECORD TYPE: FULLTEXT
DOCUMENT TYPE: Newswire
WORD COUNT: 419
TEXT:
Teva said it has launched its generic version of Pfizer's blockbuster antidepressant Zoloft in the U.S., after a delay caused by late-stage production issues.
The Israeli drug firm has begun selling 25-, 50- and 100-mg tablets of Zoloft (sertraline HCl), indicated for the treatment of major depressive disorder, the company said Aug. 14. As the first generic drugmaker that successfully challenged the Zoloft patent, Teva will be the only generic drugmaker allowed to sell those doses of the drug for the next six months. U.S. sales of Zoloft were approximately $3.1 billion for the 12 months ending June 2006, Teva said, citing IMS Health data. In its June 30 announcement that the FDA has granted final approval to Teva
to make generic Zoloft, Teva said the company was "in receipt of final labeling and is making preparations to launch this product in the latter part of July."
. . . .
This is Teva's third generic blockbuster drug launch with marketing exclusivity this year. In April, the company launched its 10-, 20- and 40-mg versions of Bristol-Myers Squibb's cholesterol drug Pravachol (pravastatin sodium) after a protracted court battle with Apotex and the FDA
http://www.fdanews.com/gl/23--9/drugapprovals/54913-1.html (Generic Line, May 3). Brand sales of those doses were $1.5 billion for the 12 months ended December 2005, according to Teva. In late June, the company launched 5-, 10-, 20- and 40-mg generic versions of Merck cholesterol drug Zocor (simvastatin), which had U.S. sales of approximately $4.1 billion for the 12 months ended March 2006, Teva said
http://www.fdanews.com/gl/23--13/courts/57090-1.html (Generic Line, June 28).
While Teva is basking in the afterglow of three fantastic generic launches in the U.S., as that market matures, future growth will increasingly be driven by foreign generic sales as well as its brand products including Copaxone and Azilect, Merrill Lynch analyst Gregg Gilbert said in a recent research note. --
mailto:dhaddix@fdanews.com Dar Haddix
Copyright (c) 2006 Generic Line
COMPANY NAMES: BRISTOL MYERS SQUIBB; PFIZER INC; BRISTOL MYERS SQUIBB CO; MERCK AND CO INC
DESCRIPTORS: generic; Drug Approvals
DIALOG UPDATE DATE: 20060822; 18:33:14 EST
EVENT NAMES: MAJOR CORPORATIONS
GEOGRAPHIC NAMES: MIDDLE EAST; ISRAEL
INDUSTRY NAMES: PHARMACEUTICAL INDUSTRY; BIOTECHNOLOGY
SUPPLIER NUMBER: 5433.59261.a |
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