Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 2 Oct 2008 07:46:15 -0500 (CDT)
Subject: CDER New 10/1/2008
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October 1, 2008
- Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
- Drugs Shortages: Drugs to be Discontinued: SecreFlo (porcine secretin for injection, 16 mcg/vial) (updated)
- New and Generic Drug Approvals
- Cyclobenzaprine Hydrochloride Tablets, Aurobindo Pharma USA, Inc., Approval
- Gleevec (imatinib mesylate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Promethazine Hydrochloride Injection, Wockhardt USA, Inc., Approval
- Stalevo (carbidopa and entacapone and levodopa) Tablets, Orion Corp., Labeling Revision
- Tramadol Hydrochloride and Acetaminophen Tablets, Alphapharm Party, Ltd., Approval
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- Paragraph IV Patent Certifications (updated)
Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 2 Oct 2008 07:50:36 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: October 2, 2008 |
The following new items were added to the CDRH web pages on October 1, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Class I Medical Device Recall: Medtronic Neuromodulation INDURA One-Piece (IP) Intrathecal Catheters, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit |  |
| | Ophthalmic Devices Panel Advisory Meeting, June 10, 2008 - Written Comments | |
| Registration and Listing (Device Establishment Registration and Listing for FY2009 Now Available) | |
Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 2 Oct 2008 15:05:27 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Recalls, Withdrawals, Field Corrections & Notifications Update
You are subscribed to CBER's Recalls, Withdrawals, Field Corrections & Notifications for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Medical Device Notification: m2000sp Instrument - Abbott Molecular, Inc. - 8/25/2008
Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 2 Oct 2008 16:19:32 -0500 (CDT)
Subject: CDER New 10/2/2008
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October 2, 2008
- Drugs@FDA Downloadable Data Files (updated)
- Guidance for Industry: Comprehensive List of Guidance Documents
- Guidance for Industry: New/Revised/Withdrawn List for 2008
- Investigational Human Drugs: Clinical Investigator Inspection List (updated)
- New and Generic Drug Approvals
- Curosurf (poractant alpha) Intratracheal Suspension, Dey, L.P., Labeling Revision
- Didanosine Delayed-Release Capsules, Aurobindo Pharma, Approval
- EpiPen and Epi E Z Pen Jr (epinephrine) Intramuscular Injection, Meridian Medical Technologies Inc., Labeling Revision
- Exubera (insulin human [rDNA origin]) Inhalation Powder, Labeling Revision
- Reyataz (atazanavir sulfate) Capsules, Bristol-Myers Squibb Co., Patient Population Altered
- Videx Ec (didanosine) Delayed Release Capsules, Bristol-Myers Squibb Co., Patient Population Altered
- Warning Letter: Mirapex (pramipexole dihydrochloride)
Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 2 Oct 2008 08:02:47 -0500 (CDT)
Subject: Lion Pavilion Issues Alert on Undeclared Sulfites in Yulanpian Brand Dried Slices of Tender Bamboo Shoots (September 26)
Lion Pavilion Issues Alert on Undeclared Sulfites in Yulanpian Brand Dried Slices of Tender Bamboo Shoots (September 26)
Thu, 02 Oct 2008 07:44:00 -0500
Yulanpian Brand Dried Slices of Tender Bamboo Shoots is sold in a 230gram, clear plastic package with the following code: 2008.1.3 and was distributed nationwide. It is a product of China.
Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 2 Oct 2008 10:04:07 -0500 (CDT)
Subject: FDA MedWatch- Medtronic Neuromodulation INDURA One-Piece Intrathecal Catheters, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit- Class I Recall
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Medtronic and FDA notified healthcare professionals of the Class I Recall of several Medtronic intrathecal catheters and intrathecal catheter revision kits used with the implanted Medtronic SyncroMed II, SynchroMed EL, and IsoMed infusion pumps that store and deliver parenteral drugs to the intrathecal space. The products were recalled because of potential misconnections of the Medtronic Sutureless Connector Catheters from the catheter port on the pump. These misconnections have resulted in a blockage between the sutureless pump connector and the catheter port on the pump and disconnection from the pump connector. See the FDA Recall Notice for recommendations for healthcare professionals.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Class I Recall Notice regarding the above issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#INDURA
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