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GXPNews.com - FDA News and Announcements  - July 30, 2007 - August 3, 2007

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Federal Register - Meetings, Notices, &  Rule Changes
CDER Links CBER Links CDRH Links
August 3, 2007
  • Presentations from the Public Meeting on Essential Uses of Ozone Depleting Substances; August 2, 2007
  • New and Generic Drug Approvals

    -Celexa (citalopram hydrobromide) Tablets, Forest Labs, Labeling Revision

    -Celexa (citalopram hydrobromide) Oral Solution, Forest Labs, Labeling Revision

    -Cymbalta (Duloxetine HCl) Capsules, Eli Lilly Co., Labeling Revision

    -Lexapro (escitalopram oxalate) Tablets, Forest Labs, Labeling Revision

    -Lexapro (escitalopram oxalate) Oral Solution, Forest Labs, Labeling Revision

    -Nardil (phenelzine sulfate) Tablets, Pfizer Pharma, Labeling Revision

    -Parnate (tranylcypromine sulfate) Tablets, GlaxoSmithKline, Labeling Revision

    -Paxil (paroxetine HCl) Tablets, GlaxoSmithKline, Labeling Revision

    -Paxil (paroxetine HCl) Suspension, GlaxoSmithKline, Labeling Revision

    -Paxil (paroxetine HCl) Controlled-Release Tablets, GlaxoSmithKline, Labeling Revision

    -Prozac and Sarafem (fluoxetine HCl) Capsules, Eli Lilly Co., Labeling Revision

    -Prozac (fluoxetine HCl) Oral Solution, Eli Lilly Co., Labeling Revision

    -Prozac (fluoxetine HCl) Delayed Release Capsules, Eli Lilly Co., Labeling Revision

    -Sinequan (doxepin HCl) Capsules, Pfizer Pharma, Labeling Revision

    -Sinequan (doxepin HCl) Oral Concentrate, Pfizer Pharma, Labeling Revision

    -Stalevo (levodopa/carbidopa/entacapone) Tablets, Orion Corporation, Formulation Revision

    -Symbyax (olanzapine/fluoxetine HCl) capsules, Eli Lilly Co., Labeling Revision

    -Wellbutrin (bupropion HCl) Tablets, GlaxoSmithKline, Labeling Revision

    -Wellbutrin SR (bupropion HCl) Sustained-Release Tablets, GlaxoSmithKline, Labeling Revision

    -Wellbutrin XL (bupropion HCl) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision

    -Zoloft (sertraline HCl) Tablets, Pfizer Pharma, Labeling Revision

    -Zoloft (sertraline HCl) Oral Concentrate, Pfizer Pharma, Labeling Revision

    -Zyban (bupropion HCl) Extended-Release Tablet, GlaxoSmithKline, Labeling Revision 

August 2, 2007

  • Guidance for Industry: Comprehensive List of Guidance Documents PDF
  • Guidance for Industry: New/Revised/Withdrawn List for 2007 PDF
  • New and Generic Drug Approvals

    -CEFTIN (cefuroxime axetil) Oral Suspension, GlaxoSmithKline, Labeling Revision

    -Effexor (venlafaxine HCl) Tablets, Wyeth Pharma, Labeling Revision

    -Effexor XR (venlafaxine HCl) Extended-Release Capsules, Wyeth Pharma, Labeling Revision

    -Escitalopram Oxalate Capsules, King and Spalding, Approval

    -Neoral (cyclosporine) Soft Gelatin Capsules, Novartis Pharma, Labeling Revision

    -Neoral (cyclosporine) Oral Solution, Novartis Pharma, Labeling Revision

    -NORVIR (ritonavir) Capsule, Abbott Labs, Labeling Revision

    -NORVIR (ritonavir) Oral Solution, Abbott Labs, Labeling Revision

    -Ondansetron Hydrochloride Tablets, Aurobindo Pharma, Approval

    -Opcon-A Eye Drops, Bausch & Lomb, Labeling Revision

    -Oruvail (ketoprofen) Extended-Release Capsules, Wyeth Pharma, Labeling Revision

    -Proquin XR (ciprofloxacin hydrochloride) Tablets, Esprit Pharma, Labeling Revision

    -Surmontil (trimipramine maleate) Capsules, Duramed Pharma, Labeling Revision

    -Tirosint (levothyroxine sodium) Capsules, Institut Biochimique, Approval

    -VIRACEPT (nelfinavir mesylate 625mg) Tablets, Agouron Pharma, Labeling Revision

August 1, 2007

July 31, 2007

July 30, 2007

CDER Drug Links
Vacancy Announcement - Interdisciplinary Scientist, DBA/OBRR
Posted: 8/3/2008

Vacancy Announcement - Supervisory Biologist, BPB/DBA/OBRR
Posted: 8/3/2008

Vacancy Announcement - Supervisory Medical Officer, BPB/DBA/OBRR
Posted: 8/3/2008

Workshop: Licensure of Apheresis Blood Products - Updated information regarding on-site registration
Posted: 8/3/2007

Shortage Information - Hepatitis A Vaccine (VAQTA)
Posted: 8/2/2007

Influenza Virus Vaccine 2007/2008 Season Lot Release Status
Posted: 8/2/2007

Supplement Approval: Influenza Virus Vaccine (Fluvirin) - Novartis Vaccines and Diagnostics Limited
Posted: 8/1/2007, Approval Date: 7/24/2007

Supplement Approval: Influenza Virus Vaccine (Fluarix) - GlaxoSmithKline Biologicals
Posted: 8/1/2007, Approval Date: 7/24/2007

Immune Globulin Intravenous (IGIV) Indications - Updated
Posted: 8/1/2007

Vacancy Anouncement - Consumer Safety Officer, BDDCB/DCM/OCBQ
Posted: 8/1/2007

Vacancy Anouncement - Consumer Safety Officer, PSB/DIS/OCBQ
Posted: 8/1/2007

Premarket Approval - CryoSeal FS System - ThermoGenesis Corp
Posted: 7/31/2007, Approval Date: 7/26/2007

Vacancy Announcement - Senior Staff Fellow, DH/OBRR
Posted: 7/31/2007

Guidance: Emergency Use Authorization of Medical Products
Posted: 7/31/2007

Substantially Equivalent 510(k) Device - AlbaQ-Chek Simulated Whole Blood Controls - Alba Bioscience
Posted: 7/30/2007, Clearance Date: 7/27/2007

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 - Update
Posted: 7/30/2007, Updated as of: 7/28/2007

Approval Information: Hepatitis C Virus Encoded Antigens (Recombinant c100-3, HCr43, NS5) (ABBOTT PRISM HCV) - Abbott Laboratories
Posted: 7/30/2007, Approval Date: 7/11/2007


 

BER Links
August 3, 2007
* Summary Information for: CryoCor CryoAblation System PDF
* Consumer Information on: GeneSearch BLN Test Kit - P060017 Text
* Federal Register: Guidance for Industry and Food and Drug Administration Staff;Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology. TextPDF
* Information on Tanning Text
* Federal Register: Medical Devices; General and Plastic Surgery Devices; Classification of Absorbable Poly(hydorxybutyrate)Surgical Suture Produced by Recombinant DNA Technology. TextPDF
 
August 2, 2007
* Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology TextPDF
 
August 1, 2007
* Class I Medical Device Recall: Advanced Medical Optics, Inc. COMPLETE MoisturePLUS Multi-purpose Contact Lens Solution Text
* Summary Information for: FLAIR Endovascular Stent Graft PDF
 
July 31, 2007
* Guidance for Industry and FDA Staff - Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs) TextPDF
* Maturity Health Matters: FDA Health News for Older Adults and Their Caregivers (Summer 2007 Issue) Text
 
July 30, 2007
* Federal Register: Assuring Radiation Protection; Cooperative Agreement; Request for Applications: RFA-FDA-CDRH-07-004; Catalog of Federal Domestic Assistance Number: 93.103. TextPDF
* Circulatory System Devices Panel Advisory Meeting, June 27, 2007 - Slides, Transcript, Minutes Text
 

Medical Device Links

Industry Assistance

About CDRH

Device Program Areas

CFR Rule Changes this week
878 - 522 - 524 - 584 - 558
Friday, August 3, 2007

RULES
 Medical devices:
     General and plastic surgery devices—
     Absorbable polyhydroxybutyrate surgical suture; classification,
     43144–43146 [E7–15064]   [TEXT]  [PDF]

NOTICES
Grants and cooperative agreements; availability, etc.:
     Food Safety and Security Monitoring Project,
     43277–43281 [E7–15061]   [TEXT]  [PDF]

Reports and guidance documents; availability, etc.:
     Absorbable polyhydroxybutyrate surgical suture; Class II special controls,
     43282 [E7–15063]   [TEXT]  [PDF]
 
Thursday, August 2, 2007
RULES
 Animal drugs, feeds, and related products:
     Emodepside and praziquantel,
     42291 [E7–14945]   [TEXT]  [PDF]
     Oxytetracycline hydrochloride injection,
     42290–42291 [E7–14950]   [TEXT]  [PDF]

NOTICES
 Reports and guidance documents; availability, etc.:
     Animal drug user fee rates and payment procedures for (FY) 2008,
     42415–42419 [07–3782]   [TEXT]  [PDF]
 
Wednesday, August 1, 2007
NONE


 
Tuesday, July 31, 2007
RULES
 Animal drugs, feeds, and related products:
     GRAS or prior-sanctioned ingredients—
     Ethyl alcohol containing ethyl acetate,
     41619–41620 [E7–14700]   [TEXT]  [PDF]
     Ractopamine and tylosin,
     41618–41619 [E7–14699]   [TEXT]  [PDF]
 
Monday, July 30, 2007
NOTICES
 Grants and cooperative agreements; availability, etc.:
     Comprehensive radiation control program,
     41510–41511 [E7–14610]   [TEXT]  [PDF]
 

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