U.S. Food & Drug Administration (FDA) Daily Digest Bulletin
U.S. Food & Drug Administration (FDA) Daily Digest Bulletin
Update: 1
From: "U.S. Food & Drug Administration (FDA)" < fda@service.govdelivery.com>
Date: Tue, 16 Sep 2008 08:10:09 -0500 (CDT)
Subject: What's New at CBER Update
You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
13th Annual GMP by the Sea: CBER Update - Slide Presentation
Posted: 9/16/2008
Update: 2
From: "U.S. Food & Drug Administration (FDA)" < fda@service.govdelivery.com>
Date: Tue, 16 Sep 2008 09:01:11 -0500 (CDT)
Subject: CDER New 9/15/2008
September 15, 2008
Update: 3
From: "U.S. Food & Drug Administration (FDA)" < fda@service.govdelivery.com>
Date: Tue, 16 Sep 2008 09:16:24 -0500 (CDT)
Subject: FDA Data Standards Update - SPL Terminology Update
Greetings,
The FDA Data Standards Council SPL web page was updated on Tuesday, September 16, 2008, to include additional marketing category terms:
Bulk ingredient - C73626
Unapproved homeopathic - C73614
Unapproved medical gas - C73613
Unapproved other - C73627
The list of marketing category terms are located on this web page: http://www.fda.gov/oc/datacouncil/term.html#marcat.
Lonnie Smith
Project Manager
FDA Data Standards Council
Update: 4
From: "U.S. Food & Drug Administration (FDA)" < fda@service.govdelivery.com>
Date: Tue, 16 Sep 2008 11:17:35 -0500 (CDT)
Subject: What's New at CBER Update
You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
SOPP 8119: Handling of Regulatory Electronic Communications
Posted: 9/16/2008
Update: 5
From: "U.S. Food & Drug Administration (FDA)" < fda@service.govdelivery.com>
Date: Tue, 16 Sep 2008 14:05:08 -0500 (CDT)
Subject: What's New at CBER Update
You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Vacancy Announcement - Supervisory Interdisciplinary Scientist, AEB or VSB/DE/OBE
Posted: 9/16/2008
Vacancy Announcement - Supervisory Medical Officer, AEB or VSB/DE/OBE
Posted: 9/16/2008
Supplement Approval: Rotavirus Vaccine, Live, Oral, Pentavalent
Posted:9/16/2008, Approval Date: 9/5/2008
Update: 6
From: "U.S. Food & Drug Administration (FDA)" < fda@service.govdelivery.com>
Date: Tue, 16 Sep 2008 14:34:25 -0500 (CDT)
Subject: Drug Information Update- FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India.
The Warning Letters identify the agency's concerns about deviations from U.S. current Good Manufacturing Practice (cGMP) requirements at Ranbaxy's manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit), in India. Because of the extent and nature of the violations, FDA today issued an Import Alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients (API) (the primary therapeutic component of a finished drug product) and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States.
The problems at these two Ranbaxy plants relate to deficiencies in the company's drug manufacturing process. These actions are proactive measures that the FDA is taking in order to assure that all drugs that reach the American public are manufactured according to cGMP requirements. While this action does not involve removing products from the market, FDA has no evidence to date that Ranbaxy has shipped defective products. We will continue to monitor the situation.
Today's announcement does not impact products from Ranbaxy's other plants which are not affected by today's actions. FDA has inspected those facilities and, to date, they have met U.S. cGMP requirements for drug manufacturing.
The FDA recommends that consumers continue taking their medications manufactured by Ranbaxy and not disrupt their drug therapy, which could jeopardize their health. Patients who are concerned about their medications should discuss their concerns with their health care professional.
Ranbaxy is one of the largest foreign suppliers of generic drugs to the United States. The company makes a number of drug products.
The FDA Import Alert covers more than 30 different generic drug products produced in multiple dosage forms and dosage amounts ( i.e., 25 mg, 50 mg, and 100 mg) at these two locations. FDA has evaluated whether these actions would create any potential drug shortages in the United States, and has determined that other suppliers can meet market demand, with one exception. Because Ranbaxy is the sole supplier to the U.S. of one drug product, Ganciclovir oral capsules (an antiviral drug), to avoid creating a shortage of the drug, FDA generally will not detain shipments of this product, and plans to arrange for additional oversight and controls until the company resolves these manufacturing issues.
For a list of drugs manufactured at the Dewas and Paonta Sahib Facilities of Ranbaxy Laboratories, Ltd., please visit: http://www.fda.gov/cder/drug/infopage/ranbaxy/ranbaxy_list.htm
For more information, please visit:
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01886.html
http://www.fda.gov/cder/drug/infopage/ranbaxy/qa.htm
Update: 7
From: "U.S. Food & Drug Administration (FDA)" < fda@service.govdelivery.com>
Date: Tue, 16 Sep 2008 11:03:47 -0500 (CDT)
Subject: Ralston Foods Issues Allergy Alert For Undeclared Milk Ingredients In Western Family Variety Pack Instant Oatmeal (September 15)
Ralston Foods Issues Allergy Alert For Undeclared Milk Ingredients In Western Family Variety Pack Instant Oatmeal (September 15)
Tue, 16 Sep 2008 10:31:00 -0500
Ralston Foods, Division of Ralcorp Holdings, Inc. is recalling 14664 cartons of Western Family Variety Pack Instant Oatmeal cereal bearing the "Best If Used By" Date Code of "DEC0409N" (found on the box top) because a small number of cartons contain an undeclared milk ingredient.
Update: 8
From: "U.S. Food & Drug Administration (FDA)" < fda@service.govdelivery.com>
Date: Tue, 16 Sep 2008 11:21:24 -0500 (CDT)
Subject: FDA MedWatch - August 2008 Drug Safety-Related Labeling Changes for 41 Drugs Now Available on Web
The August 2008 posting includes 41 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS.
The "Summary Page" provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/medwatch/safety/2008/aug08_quickview.htm
The "Detailed View Page" identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
http://www.fda.gov/medwatch/safety/2008/aug08.htm
In August 2008, the following drugs had modifications to the BOXED WARNING and/or CONTRAINDICATIONS sections:
Abilify (aripiprazole) Tablets, Abilify Discmelt (aripiprazole) Orally Disintegrating Tablets, Abilify (aripiprazole) Oral Solution, and Abilify (aripiprazole) Injection For Intramuscular Use Only
Clozaril (clozapine HCl) Tablets
FazaClo (clozapine) Orally Disintegrating Tablets
Geodon (ziprasidone HCl) Capsules and Geodon (ziprasidone mesylate) for Injection - For IM Use Only
Haldol (haloperidol injection) For Immediate Release
Haldol Decanoate (haloperidol) For IM Injection Only
Invega (paliperidone) Extended-Release Tablets
Moban (molindone hydrochloride tablets, USP)
Navane (thiothixene capsules) and Navane (thiothixene hydrochloride concentrate)
Risperdal (risperidone) Tablets, Risperdal (risperidone) Oral Solution, and Risperdal M-Tab (risperidone) Orally Disintegrating Tablets
Risperdal Consta (risperidone) Long-Acting Injection
Seroquel (quetiapine fumarate) Tablets
Seroquel XR (quetiapine fumarate) Extended-Release Tablets
Symbyax (olanzapine and fluoxetine HCl capsules)
Viread (tenofovir disoproxil fumarate) Tablets
Zyprexa (olanzapine tablets), Zyprexa Zydis (olanzapine orally disintegrating tablets), and Zyprexa IntraMuscular (olanzapine for injection)
Metadate CD (methylphenidate HCl, USP) Extended-Release Capsules
Reyataz (atazanavir sulfate) Capsules
Rocephin (ceftriaxone sodium) For Injection
Update: 9
From: "U.S. Food & Drug Administration (FDA)" < fda@service.govdelivery.com>
Date: Tue, 16 Sep 2008 13:03:04 -0500 (CDT)
Subject: In-Body Pediatric Devices Pose Unique Challenges
In-Body Pediatric Devices Pose Unique Challenges
Tue, 16 Sep 2008 12:45:00 -0500
Implantable pediatric medical devices are exciting examples of cutting-edge medical technology. But they require special considerations on the part of parents, health professionals, and scientists who design devices.
Update: 10
From: "U.S. Food & Drug Administration (FDA)" < fda@service.govdelivery.com>
Date: Tue, 16 Sep 2008 14:02:55 -0500 (CDT)
Subject: FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India
FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India
Tue, 16 Sep 2008 13:30:00 -0500
The Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India. Because of the extent and nature of the violations, FDA today issued an Import Alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
Update: 1
From: "U.S. Food & Drug Administration (FDA)" < fda@service.govdelivery.com>
Date: Tue, 16 Sep 2008 08:10:09 -0500 (CDT)
Subject: What's New at CBER Update
You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
13th Annual GMP by the Sea: CBER Update - Slide Presentation
Posted: 9/16/2008
Update: 2
From: "U.S. Food & Drug Administration (FDA)" < fda@service.govdelivery.com>
Date: Tue, 16 Sep 2008 09:01:11 -0500 (CDT)
Subject: CDER New 9/15/2008
September 15, 2008
- New and Generic Drug Approvals
- Alendronate Sodium cialis, Sun Pharmaceutical Industries, Ltd., Approval
- Detrol (tolterodine tartrate) Tablets, Pfizer Global Pharmaceuticals, Labeling Revision
- Detrol LA (tolterodine tartrate) Extended-Release Capsules, Pfizer Global Pharmaceuticals, Labeling Revision
- Galantamine Hydrobromide Tablets, Dr. Reddy's Laboratories, Ltd., Approval
- NeoProfen (ibuprofen lysine) Intravenous Injection, Ovation Pharmaceuticals, Inc., Labeling Revision
- Potassium Chloride 0.149% in Sodium Chloride 0.45% in Plastic Container (potassium chloride and sodium chloride) Injection, Hospira Inc., Approval
- Remodulin (treprostinil sodium) Subcutaneous I.V. Injection, United Therapeutics Corp., Labeling Revision
- Stromectol (ivermectin) Tablets, Merck & Co., Inc., Labeling Revision
Update: 3
From: "U.S. Food & Drug Administration (FDA)" < fda@service.govdelivery.com>
Date: Tue, 16 Sep 2008 09:16:24 -0500 (CDT)
Subject: FDA Data Standards Update - SPL Terminology Update
Greetings,
The FDA Data Standards Council SPL web page was updated on Tuesday, September 16, 2008, to include additional marketing category terms:
Bulk ingredient - C73626
Unapproved homeopathic - C73614
Unapproved medical gas - C73613
Unapproved other - C73627
The list of marketing category terms are located on this web page: http://www.fda.gov/oc/datacouncil/term.html#marcat.
Lonnie Smith
Project Manager
FDA Data Standards Council
Update: 4
From: "U.S. Food & Drug Administration (FDA)" < fda@service.govdelivery.com>
Date: Tue, 16 Sep 2008 11:17:35 -0500 (CDT)
Subject: What's New at CBER Update
You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
SOPP 8119: Handling of Regulatory Electronic Communications
Posted: 9/16/2008
Update: 5
From: "U.S. Food & Drug Administration (FDA)" < fda@service.govdelivery.com>
Date: Tue, 16 Sep 2008 14:05:08 -0500 (CDT)
Subject: What's New at CBER Update
You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Vacancy Announcement - Supervisory Interdisciplinary Scientist, AEB or VSB/DE/OBE
Posted: 9/16/2008
Vacancy Announcement - Supervisory Medical Officer, AEB or VSB/DE/OBE
Posted: 9/16/2008
Supplement Approval: Rotavirus Vaccine, Live, Oral, Pentavalent
Posted:9/16/2008, Approval Date: 9/5/2008
Update: 6
From: "U.S. Food & Drug Administration (FDA)" < fda@service.govdelivery.com>
Date: Tue, 16 Sep 2008 14:34:25 -0500 (CDT)
Subject: Drug Information Update- FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India.
The Warning Letters identify the agency's concerns about deviations from U.S. current Good Manufacturing Practice (cGMP) requirements at Ranbaxy's manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit), in India. Because of the extent and nature of the violations, FDA today issued an Import Alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients (API) (the primary therapeutic component of a finished drug product) and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States.
The problems at these two Ranbaxy plants relate to deficiencies in the company's drug manufacturing process. These actions are proactive measures that the FDA is taking in order to assure that all drugs that reach the American public are manufactured according to cGMP requirements. While this action does not involve removing products from the market, FDA has no evidence to date that Ranbaxy has shipped defective products. We will continue to monitor the situation.
Today's announcement does not impact products from Ranbaxy's other plants which are not affected by today's actions. FDA has inspected those facilities and, to date, they have met U.S. cGMP requirements for drug manufacturing.
The FDA recommends that consumers continue taking their medications manufactured by Ranbaxy and not disrupt their drug therapy, which could jeopardize their health. Patients who are concerned about their medications should discuss their concerns with their health care professional.
Ranbaxy is one of the largest foreign suppliers of generic drugs to the United States. The company makes a number of drug products.
The FDA Import Alert covers more than 30 different generic drug products produced in multiple dosage forms and dosage amounts ( i.e., 25 mg, 50 mg, and 100 mg) at these two locations. FDA has evaluated whether these actions would create any potential drug shortages in the United States, and has determined that other suppliers can meet market demand, with one exception. Because Ranbaxy is the sole supplier to the U.S. of one drug product, Ganciclovir oral capsules (an antiviral drug), to avoid creating a shortage of the drug, FDA generally will not detain shipments of this product, and plans to arrange for additional oversight and controls until the company resolves these manufacturing issues.
For a list of drugs manufactured at the Dewas and Paonta Sahib Facilities of Ranbaxy Laboratories, Ltd., please visit: http://www.fda.gov/cder/drug/infopage/ranbaxy/ranbaxy_list.htm
For more information, please visit:
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01886.html
http://www.fda.gov/cder/drug/infopage/ranbaxy/qa.htm
Update: 7
From: "U.S. Food & Drug Administration (FDA)" < fda@service.govdelivery.com>
Date: Tue, 16 Sep 2008 11:03:47 -0500 (CDT)
Subject: Ralston Foods Issues Allergy Alert For Undeclared Milk Ingredients In Western Family Variety Pack Instant Oatmeal (September 15)
Ralston Foods Issues Allergy Alert For Undeclared Milk Ingredients In Western Family Variety Pack Instant Oatmeal (September 15)
Tue, 16 Sep 2008 10:31:00 -0500
Ralston Foods, Division of Ralcorp Holdings, Inc. is recalling 14664 cartons of Western Family Variety Pack Instant Oatmeal cereal bearing the "Best If Used By" Date Code of "DEC0409N" (found on the box top) because a small number of cartons contain an undeclared milk ingredient.
Update: 8
From: "U.S. Food & Drug Administration (FDA)" < fda@service.govdelivery.com>
Date: Tue, 16 Sep 2008 11:21:24 -0500 (CDT)
Subject: FDA MedWatch - August 2008 Drug Safety-Related Labeling Changes for 41 Drugs Now Available on Web
The August 2008 posting includes 41 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS.
The "Summary Page" provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/medwatch/safety/2008/aug08_quickview.htm
The "Detailed View Page" identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
http://www.fda.gov/medwatch/safety/2008/aug08.htm
In August 2008, the following drugs had modifications to the BOXED WARNING and/or CONTRAINDICATIONS sections:
Abilify (aripiprazole) Tablets, Abilify Discmelt (aripiprazole) Orally Disintegrating Tablets, Abilify (aripiprazole) Oral Solution, and Abilify (aripiprazole) Injection For Intramuscular Use Only
Clozaril (clozapine HCl) Tablets
FazaClo (clozapine) Orally Disintegrating Tablets
Geodon (ziprasidone HCl) Capsules and Geodon (ziprasidone mesylate) for Injection - For IM Use Only
Haldol (haloperidol injection) For Immediate Release
Haldol Decanoate (haloperidol) For IM Injection Only
Invega (paliperidone) Extended-Release Tablets
Moban (molindone hydrochloride tablets, USP)
Navane (thiothixene capsules) and Navane (thiothixene hydrochloride concentrate)
Risperdal (risperidone) Tablets, Risperdal (risperidone) Oral Solution, and Risperdal M-Tab (risperidone) Orally Disintegrating Tablets
Risperdal Consta (risperidone) Long-Acting Injection
Seroquel (quetiapine fumarate) Tablets
Seroquel XR (quetiapine fumarate) Extended-Release Tablets
Symbyax (olanzapine and fluoxetine HCl capsules)
Viread (tenofovir disoproxil fumarate) Tablets
Zyprexa (olanzapine tablets), Zyprexa Zydis (olanzapine orally disintegrating tablets), and Zyprexa IntraMuscular (olanzapine for injection)
Metadate CD (methylphenidate HCl, USP) Extended-Release Capsules
Reyataz (atazanavir sulfate) Capsules
Rocephin (ceftriaxone sodium) For Injection
Update: 9
From: "U.S. Food & Drug Administration (FDA)" < fda@service.govdelivery.com>
Date: Tue, 16 Sep 2008 13:03:04 -0500 (CDT)
Subject: In-Body Pediatric Devices Pose Unique Challenges
In-Body Pediatric Devices Pose Unique Challenges
Tue, 16 Sep 2008 12:45:00 -0500
Implantable pediatric medical devices are exciting examples of cutting-edge medical technology. But they require special considerations on the part of parents, health professionals, and scientists who design devices.
Update: 10
From: "U.S. Food & Drug Administration (FDA)" < fda@service.govdelivery.com>
Date: Tue, 16 Sep 2008 14:02:55 -0500 (CDT)
Subject: FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India
FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India
Tue, 16 Sep 2008 13:30:00 -0500
The Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India. Because of the extent and nature of the violations, FDA today issued an Import Alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420