Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition
You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
- - - original post below - - -
It finally arrived!
The FDA Orange Book for 2012 (32nd Edition) has just been posted. It's current through Dec 31, 2011.
It's also posted in this location:
FDA - Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations: Publications
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Showing posts with label therapeutic. Show all posts
Showing posts with label therapeutic. Show all posts
Monday, February 6, 2012
It's Here! 2012 FDA Orange Book!
Monday, May 16, 2011
FDA Orange Book - New - Updated For 2011
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)
You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
- - - original post below - - -
There's been a lot of interest in the FDA's Orange Book by readers. Therefore, I'm pushing this information out to folks, so that they're aware.
It's here, the FDA's Orange Book 2011 - Approved Drug Products With Therapeutic Equivalence Evaluations 31st Edition (PDF). This volume is current through December 31, 2010.
If you want to search the Orange Book in other ways, go to the FDA's webpage, FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
Happy hunting!
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Thursday, March 3, 2011
FDA Orange Book 2011 - It Just Arrived!
It's here! The latest Orange Book Annual Edition
You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
- - - original post below - - -
I've been watching and waiting for this to be released.
It's here, the FDA's Orange Book 2011 - Approved Drug Products With Therapeutic Equivalence Evaluations 31st Edition (PDF). This volume is current through December 31, 2010.
If you want to search the Orange Book in other ways, go to the FDA's webpage, FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
Happy hunting!
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Monday, August 9, 2010
FDA Orange Book - Most Current Versions
Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)
Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition
You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
- - - original post follows below - - -
The FDA ensures that the Orange Book data files are kept current. Every effort has been made to prevent errors and discrepancies in the Approved Drug Products data files.
You can go to this FDA page to find the latest versions of the Orange Book, FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Included are the annual edition, supplements, and more, for this publication that identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act.
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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)
Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition
You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
- - - original post follows below - - -
The FDA ensures that the Orange Book data files are kept current. Every effort has been made to prevent errors and discrepancies in the Approved Drug Products data files.
You can go to this FDA page to find the latest versions of the Orange Book, FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Included are the annual edition, supplements, and more, for this publication that identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act.
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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
Monday, March 22, 2010
New - FDA Orange Book
Updated May 26, 2022
The original link broke. You might also be interested in:
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations - a webpage
--- the original post follows below ---
It's here! The February 2010 supplement of the FDA's Orange Book, APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS - 30th EDITION - Cumulative Supplement 02 - February 2010 (pdf).
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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations - a webpage
It's here! The February 2010 supplement of the FDA's Orange Book, APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS - 30th EDITION - Cumulative Supplement 02 - February 2010 (pdf).
Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
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Saturday, February 20, 2010
Univ of CA CMCR - Evidence Cannabis Is A Promising Treatment
Image via Wikipedia"The CMCR has successfully conducted the first clinical trials of smoked cannabis in the United States in more than 20 years. As a result of this program of systematic research, we now have reasonable evidence that cannabis is a promising treatment in selected pain syndromes caused by injury or diseases of the nervous system, and possibly for painful muscle spasticity due to multiple sclerosis."Learn More:
Understanding Marijuana: A New Look at the Scientific Evidence
Return Home: http://drughealth.blogspot.com/
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Wednesday, April 29, 2009
FDA - Flu Meds and Swine Flu Tests
The U.S. Food and Drug Administration (FDA), in response to requests from the U.S. Centers for Disease Control (CDC) and Prevention, has issued Emergency Use Authorizations (EUAs) to make available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the swine flu virus under certain circumstances. The agency issued these EUAs for the use of certain Relenza and Tamiflu antiviral products, and for the rRT-PCR Swine Flu Panel diagnostic test, reports this FDA news release, "FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans." In essence, this authorizes the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products, made possible by this determination and declaration of emergency, provided certain criteria are met. The authorization ends when the declaration of emergency is terminated or the authorization revoked by the agency.
Return Home: http://drughealth.blogspot.com/
Monday, April 27, 2009
FDA Makes Zometa Inj Orange Book Decision
- GMP Online Training. FDA cGMP QSR GMP online training classes offered by SkillsPlus International Inc.
It's here! The latest Orange Book Annual Edition
You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
- - original post below - -
The Food and Drug Administration (FDA) has determined that ZOMETA (zoledronic acid for injection), equivalent to (EQ) 4 milligrams (mg) base/vial, lyophilized powder for injection, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for zoledronic acid lyophilized powder for injection, 4-mg base/vial. The Federal Register published the FDA docket "Determination That ZOMETA (Zoledronic Acid for Injection), Equivalent to 4 Milligrams Base Per Vial, Lyophilized Powder for Injection, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (pdf)."
According to IP Pharma Doc's post, Zoledronic acid (ZOMETA) lyophilized powder for injection: USFDA confirmed that drug was not withdrawn due to safety issues, this decision will allow US FDA to approve ANDA's for the innovator's (Novartis) discontinued product (in May, 2003).
Kurt Karst posts an in-depth analysis and commentary related to the FDA decision, Attention Orange Book Junkies: FDA Petition Response Cements Orange Book Preface Therapeutic Equivalence Clarification.
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Wednesday, March 4, 2009
FDA Orange Book Online - Brand New Edition
Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)
Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition
- - - original post below - - -
You've been waiting for this. A brand new 29th edition, the 2009 FDA Orange Book Online. The products in this FDA Orange Book have been approved under section 505 of the Federal Food, Drug, and Cosmetic Act. This volume, the 29th edition, is current through December 31, 2008.
According to the FDA, "This publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act). Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal® Tablets and Librax® Capsules] or pre-1938 drugs [e.g., Phenobarbital Tablets]) are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product. In addition, the List contains therapeutic equivalence evaluations for approved multisource prescription drug products. These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs. Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act."
Related Posts:
Easy FDA Orange Book Search Widget
About The FDA Orange Book - Slide Deck (free)
FDA Orange Book - Online
Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)
Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition
- - - original post below - - -
You've been waiting for this. A brand new 29th edition, the 2009 FDA Orange Book Online. The products in this FDA Orange Book have been approved under section 505 of the Federal Food, Drug, and Cosmetic Act. This volume, the 29th edition, is current through December 31, 2008.
According to the FDA, "This publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act). Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal® Tablets and Librax® Capsules] or pre-1938 drugs [e.g., Phenobarbital Tablets]) are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product. In addition, the List contains therapeutic equivalence evaluations for approved multisource prescription drug products. These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs. Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act."
Related Posts:
Easy FDA Orange Book Search Widget
About The FDA Orange Book - Slide Deck (free)
FDA Orange Book - Online
Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
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