From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 29 Jul 2008 07:56:38 -0500 (CDT)
Subject: CDRH New Update
    |
| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
 | ||
 | Date: July 29, 2008 |
The following new items were added to the CDRH web pages on July 28, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Summary Information for: ELA Ovatio CRT-D System |  |
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 29 Jul 2008 13:01:54 -0500 (CDT)
Subject: CDER New7/28/2008
| ||||||||||||
July 28, 2008
- DIA/FDA/PhRMA Drug Safety Conference: Planning the Lifecycle of Safety Evaluation. October 14, Arlington, VA. Meeting information and registration
- Drug Safety Oversight Board Meeting, June 19, 2008
- New and Generic Drug Approvals
- Capastat Sulfate (capreomycin sulfate) Injection, Eli Lilly and Co., Labeling Revision
- Ceftriaxone (ceftriaxone sodium) Injection, ACS Dobfar, SPA, Approval
- Ceftriaxone (ceftriaxone sodium) Injection, ACS Dobfar, SPA, Approval
- Elmiron (pentosan polysulfate sodium) Capsules, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
- Lopressor (metoprolol tartrate) Injection, Novartis Pharmaceuticals Corp., Labeling Revision
- Lopressor (metoprolol tartrate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Nicardipine Hydrochloride Injection, Teva Parenteral Medicines, Approval
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 29 Jul 2008 13:03:52 -0500 (CDT)
Subject: EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient
EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient
Tue, 29 Jul 2008 12:41:00 -0500
EG Labs, LLC, announced today that it is conducting a nationwide voluntary recall of all lots of its supplement product sold under the brand name, Viapro, in 375mg capsules. EG Labs, LLC. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, thio-methisosildenafil.
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 29 Jul 2008 15:03:48 -0500 (CDT)
Subject: FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder
FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder
Tue, 29 Jul 2008 14:56:00 -0500
The U.S. Food and Drug Administration today approved the first generic version of Depakote delayed-release tablets (divalproex sodium). Depakote is approved by the FDA for the treatment of seizures, bipolar disorder and migraine headaches.
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 29 Jul 2008 16:06:12 -0500 (CDT)
Subject: Mammography What's New Update
You are subscribed to Mammography What's New for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Incompatibility - Some FFDM Units and Some PACS?
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 29 Jul 2008 14:31:01 -0500 (CDT)
Subject: MedWatch - Mitoxantone (marketed as Novantrone and generics): updated cardiotoxicity warnings/recommendations
  |
Mitoxantrone Hydrochloride (marketed as Novantrone and generics)
Audience: Neurological and Oncological healthcare professionals, risk managers
FDA reminded health care professionals who treat patients with mitoxantrone about recommendations that left ventricular ejection fraction (LVEF) be evaluated before initiating treatment and prior to administering each dose of mitoxantrone. FDA offered additional recommendations for cardiac monitoring to detect late-occurring cardiac toxicity, and provided information for patients with multiple sclerosis who receive the drug. These recommendations were established in 2005 in response to post-marketing reports and case reports in the medical literature that described decreases in LVEF or frank congestive heart failure in patients with MS who had received cumulative doses of mitoxantrone that were lower than 100 mg/m2. Since that time, FDA has received information from a post-marketing safety study that demonstrated there is poor adherence to these recommendations in clinical practice. FDA is working with the manufacturers to educate healthcare providers to adhere to cardiac monitoring recommendations for patients with MS.
Read the complete MedWatch 2008 Safety summary, including links to the Information for Healthcare Professionals sheet and the previous 2005 safety alert, at: http://internet-dev.fda.gov/medwatch/safety/2008/safety08.htm#Mitoxantrone
Update: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 29 Jul 2008 14:56:48 -0500 (CDT)
Subject: FDA MedWatch - June 2008 Drug Safety-Related Labeling Changes for 51 Drugs Now Available on Web
| |
The June 2008 posting includes 51 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.
The "Summary Page" provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/medwatch/SAFETY/2008/jun08_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/jun08.htm
In June 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or MEDICATION GUIDES:
Optison (Perflutren Protein -Type A Microspheres Injectable Suspension, USP)
Viramune (nevirapine) Tablets and Oral Suspension
Aptivus (tipranavir) Capsules and Oral Solution
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets
Avodart (dutasteride) Soft Gelatin Capsules
Concerta (methylphenidate HCl) Extended-Release Tablets
Kaletra (lopinavir and ritonavir) Tablet, Film Coated for Oral Use
Kaletra (lopinavir and ritonavir) Solution for Oral Use
Reclast (zoledronic acid) Injection
Zyvox (linezolid) Injection, Zyvox (linezolid) Tablets, and Zyvox (linezolid) for Oral Suspension
Forteo (teriparatide [rDNA origin]) Injection
PegIntron/REBETOL Combo Pack containing: PegIntron REDIPEN Single-dose Delivery System (peginterferon alfa-2b) and REBETOL (ribavirin, USP) Capsules
Update: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 29 Jul 2008 19:50:08 -0500 (CDT)
Subject: MedWatch - Correction to previous Mitoxantrone alert: link to web posting provided
| |
The Mitoxantrone safety alert sent you earlier today had a broken [non-functioning] link to the FDA MedWatch webpage that provides the details of the new safety information. The correct link is: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Mitoxantrone
Our apologies for any inconvenience. We appreciate your interest in, and support of, our FDA medical product safety efforts.
GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
