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GXPNews.com - FDA News and Announcements - December 24, 2007 - December 28, 2007

The once a week newsletter reporting on what's new within the Food and Drug Administration (FDA)
Distributed by the worlds leader in Federal Regulations, GMP Publications & FDA.COM - John Cuspilich RA/QA Editor

Home | New! | Drug GMPs | Clinical & Laboratory | Device & Part 11 | Food-Dietary-Cosmetic | Biologic-Cell-Blood | EU-Can-ISO-ICH-OECD-Guidance-Misc.

NOTE: Changes to the Drug GMPs Parts 210 & 211 - Dec. 4th.!
This Week - New Changes Parts 201, 312, 314, 601, 610, 801, 807, 809, 812, & 814 - Order new updates at GMP Publications.com!

Center for Drug Evaluation &
Research (CDER) News

(CBER) Center for Biologics Evaluation & Research

Center for Device & Radiological Health (CDRH)

Federal Register - Meetings, Notices, & Rule Changes

View CDER Handbooks

View CBER Handbooks

View CDRH Handbooks

December 28, 2007

On 12/27/2007, the drug Torsemide from Bedford Laboratories was mistakenly listed as approved. Torsemide Injection from Bedford Laboratories has NOT been approved.
New and Generic Drug Approvals
- Ambienn CR (zolpidem tartrate) Tablets, Sanofi Aventis, New or Modified Indication
- AndroGel (testosterone gel), Solvay Pharma, Labeling Revision
- Brovana (Arformoterol Tartrate) Solution, Sepracor Inc., Package Change
- Cetirizine Hydrochloride Tablets, Perrigo R&D, Approval
- Claritin (loratadine) Tablets, Schering-Plough, Labeling Revision
- Exjade (deferasirox) Tablets Oral Suspension, Novartis Pharma, Labeling Revision
- Invega (paliperidone ER) Tablets, Johnson & Johnson, Efficacy Supp. w/Clinical Data
- Minocycline Hydrochloride Tablets, Indicus Pharma, Approval
- Mondox (doxycycline monohydrate) Capsules, Watson Labs, Labeling Revision
- Paclitaxel Injection, EBEWE Pharma, Approval
- Premarin (Conjugated Estrogens) Cream, Wyeth Pharma, Labeling Revision
- Protonix (pantoprazole sodium) Delayed-Release Tablets, Wyeth Pharma, Labeling Revision
- Protonix I.V. (pantoprazole sodium) Injection, Wyeth Pharma, Labeling Revision
- Reyataz (atazanavir) Capsules, Bristol-Myers Squibb, Labeling Revision
- Valacyclovir Hydrochloride Tablets, Matrix Labs, Tentative Approval
- Zegerid (omeprazole/sodium bicarbonate) Capsules, Santarus, Inc., Formulation Revision

December 27, 2007

New and Generic Drug Approvals
- Biaxin (clarithromycin) Tablets Filmtabs, Abbott Labs, Labeling Revision
- Biaxin (clarithromycin) Oral Suspension Granules, Abbott Labs, Labeling Revision
- Biaxin (clarithromycin) Extended-Release Tablets XL Filmtabs, Abbott Labs, Labeling Revision
- CellCept (mycophenolate mofetil) Capsules, Roche Palo Alto, Labeling Revision
- CellCept (mycophenolate mofetil) Tablets, Roche Palo Alto, Labeling Revision
- CellCept (mycophenolate mofetil hydrochloride) Intravenous, Roche Palo Alto, Labeling Revision
- CellCept (mycophenolate mofetil) Oral Suspension, Roche Palo Alto, Labeling Revision
- Doryx (doxycycline hyclate) Delayed Release Tablets, Warner Chilcott, Labeling Revision
- DOSTNEX (cabergoline) Tablets, Pfizer Inc., Labeling Revision
- Equetro (carbamazepine) Extended-Release Capsules, Validus Pharma, Labeling Revision
- Factive (gemifloxacin) Tablets, Oscient Pharma, Labeling Revision
- Fludara (fludarabine phosphate) Injection, Bayer HealthCare, Labeling Revision
- Galantamine Hydrobromide Oral Solution, Ranbaxy Labs, Tentative Approval
- Gonal f RFF Pen (follitropin alfa) Injection, EMD Serono Inc., Labeling Revision
- HEPSERA (adefovir dipivoxil) Tablets, Gilead Sciences, Patient Population Altered
- Luvox (fluvoxamine maleate) Tablets, Solvay Pharma, Approval
- Niaspan (niacin) Extended-Release Tablets, Abbott Labs, Labeling Revision
- Pepcid AC (famotidine) Chewable Tablet, Merck & Co., New Dosage Regimen
- Ranexa (ranolazine) Extended-Release (ER) Tablets, CV Therapeutics, Labeling Revision
- Tirosint (levothyroxine sodium) Capsules, Institut Biochimique, Labeling Revision
- Veregen (sinecatechins) Ointment, MediGene Inc., Efficacy Supp. w/Clinical Data

December 26, 2007

CDER Drug Links

Market Withdrawal of Octagam
Posted: 12/28/2007; Withdrawal Date: 12/24/2007

Medical Device Notification: Sunquest Laboratory Blood Bank Module
Posted: 12/28/2007; Notification Date: 12/14/2007

Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile; Interim Final Rule; Request for Comments
Posted: 12/28/2007

Immune Correlates of Protection Against Influenza A Viruses in Support of Pandemic Vaccine Development - Slide Presentations
Posted: 12/27/2007

6% Hydroxyethyl Starch in 0.9% Sodium Chloride Infusion (Voluven 500 mL freeflex flexible plastic intravenous solution container), Fresenius Kabi
Posted: 12/27/2007

FDA Approves Voluven to Treat Serious Blood Volume Loss following Surgery
Posted: 12/27/2007

Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions; Correction
Posted: 12/26/2007

December 27, 2007
	Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements

December 21, 2007
	FDA Medical Device Industry Coalition - 'Quality Systems Educational Forum on Design Controls'
	Consumer Information on: ProDisc-C Total Disc Replacement - P070001

Medical Device Links

Industry Assistance

Weekly CFR Rule Changes - 201, 312, 314, 601, 610, 801, 807, 809, 812, & 814 - 510

Friday, Dec. 28, 2007

RULES
Human drugs, biological products, or medical devices:
     Strategic National Stockpile; product labeling requirements; exceptions or alternatives,
     73589–73602 [E7–25165]   [TEXT]  [PDF]

NOTICES
Meetings:
     Cellular, Tissue, and Gene Therapies Advisory Committee,
     73850–73851 [E7–25124]   [TEXT]  [PDF]

Reports and guidance documents; availability, etc.:
     Prescription Drug User Fee Act IV Information Technology Plan; comment availability,
     73851–73852 [E7–25310]   [TEXT]  [PDF]

Thursday, Dec. 27, 2007

NONE

Wednesday, Dec. 26, 2007

RULES
Animal drugs, feeds, and related products:
     Sponsor name and address changes—
     Nycomed US, Inc.,
     72920–72921 [E7–24974]   [TEXT]  [PDF]

NOTICES
Agency information collection activities; proposals, submissions, and approvals; correction,
73028 [E7–24914]   [TEXT]  [PDF]

Color additive petitions:
     DSM Nutritional Products, Inc; correction,
     73028 [E7–24911]   [TEXT]  [PDF]

Meetings:
     Community-acquired pneumonia clinical trial design; public workshop,
     73028–73029 [E7–24927]
     Public health benefit of adverse event collection; workshop and comment request,
     73029–73030 [E7–24960]   [TEXT]  [PDF]

Tuesday, Dec. 25, 2007

NONE

Monday, Dec. 24, 2007

NONE

2007 FDA Handbooks