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October 26,
2006
October
25, 2006
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CDER
Organization Charts [HTML]
[PDF]
(updated)
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Drugs@FDA
Downloadable Data Files
(updated)
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Heartland
Repack Services and FDA notify
healthcare professionals of a
voluntary recall of all products
containing a lot number
beginning with “K” (example:
K12345).
MedWatch Safety Information
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New and Generic
Drug Approvals
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Avandaryl
(rosiglitazone maleate and
glimepiride) Tablets, SB
Pharmco, New or Modified
Indication
-
Cialis
(tadalafil), Lilly ICOS,
Labeling Revision
-
Colestipol
Hydrochloride Tablets, Impax
Labs, Approval
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CUBICIN
(daptomycin injection),
Cubist Pharma, Labeling
Revision
-
Pravastatin
Sodium Tablets, Lek Pharma,
Approval
-
Pravastatin
Sodium Tablets, Genpharm
Inc., Approval/Tentative
Approval
-
Pravastatin
Sodium Tablets, Watson Labs,
Approval/Tentative Approval
-
Pravastatin
Sodium Tablets, Cobalt
Pharma, Approval/Tentative
Approval
-
Pravastatin
Sodium Tablets, Dr. Reddy’s
Labs, Approval/Tentative
Approval
-
Pravastatin
Sodium Tablets, Apotex Inc.,
Approval/Tentative Approval
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Sodium Iodide
I 131 Capsule USP, Draxis
Specialty Pharma, Labeling
Revision
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Vytorin
(ezetimibe/simvastatin)
Tablets, Merck & Co.,
Labeling Revision
-
Wyeth and FDA
notify healthcare professionals
of revisions to the Overdosage/Human
Experience section of the
prescribing information for
Effexor (venlafaxine HCl),
indicated for treatment of major
depressive disorder.
MedWatch Safety Information
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Warning Letters:
Ontak and Targretin
October
24, 2006
October
23, 2006
-
FDA approves
Omnaris (ciclesonide) nasal
spray for the treatment of nasal
symptoms associated with
seasonal and perennial allergic
rhinitis, commonly known as hay
fever.
FDA News
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New and Generic
Drug Approvals
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Abilify
(aripiprazole) Tablets,
Otsuka, Labeling Revision
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Abilify
(aripiprazole) Oral
Solution, Otsuka, Labeling
Revision
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Abilify
Discmelt (aripiprazole)
Orally Disintegrating
Tablets, Otsuka, Labeling
Revision
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Coreg CR
(carvedilol phosphate)
Extended-Release Capsules,
GlaxoSmithKline, Approval
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Desonate
(desonide) Gel, Dow Pharma,
Approval
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Effexor
(venlafaxine hydrochloride)
Immediate Release Tablets,
Wyeth Pharma, Labeling
Revision
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Effexor XR
(venlafaxine hydrochloride)
Extended Release Capsules,
Wyeth Pharma, Labeling
Revision
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Gleevec
(imatinib mesylate) Tablets,
Novartis Pharma, New or
Modified Indication
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NEXIUM
Delayed Release Oral
Suspension, AstraZeneca,
Approval
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Noxafil
(posaconazole) Oral
Suspension, Schering Corp.,
Approval
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OMNARIS
(ciclesonide) Nasal Spray,
Altana Pharma, Approval
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Rapamune
(sirolimus) Oral Solution,
Wyeth Pharma, Labeling
Revision
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Rapamune
(sirolimus) Tabelts, Wyeth
Pharma, Labeling Revision
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Risperdal
Consta (risperidone) Long
Acting Injection, Johnson &
Johnson, Labeling Revision
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Seroquel
(quetiapine) Tablets,
AstraZeneca Pharma, New or
Modified Indication
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Sodium
Chloride
Irrigation, B. Braun,
Labeling Revision
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Strattera
(atomoxetine HCl) Capsules,
Eli Lilly & Co., Labeling
Revision
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Temodar
(temozolomide) Capsules,
Schering Corp.,
Manufacturing Change or
Addition
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Topamax
Tablets, Ortho-McNeil Pharma,
Labeling Revision
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Topamax
Sprinkle Capsules,
Ortho-McNeil Pharma,
Labeling Revision
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Zaditor
(ketotifen fumarate
ophthalmic solution),
Novartis Pharma, Labeling
Revision
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October 26, 2006 |
 |
Federal Register:
Agency Information
Collection
Activities;
Announcement of
Office of Management
and Budget;
Extension of
Expiration Date for
MedWatch (Food and
Drug Administration
Medical Products
Reporting Program)
Form.  |
|
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Federal Register:
Dental Products
Panel of the Medical
Devices Advisory
Committee; Notice of
Meeting. |
|
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Federal Register:
Draft Guidance for
Industry and Food
and Drug
Administration
Staff; Annual
Reports for Approved
Premarket Approval
Applications;
Availability. |
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October 25, 2006 |
|
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Draft
Guidance for
Industry and FDA
Staff - Annual
Reports for Approved
Premarket Approval
Applications (PMA) |
|
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Federal Register:
Draft Guidance for
Industry and Food
and Drug
Administration
Staff; Total Product
Life Cycle for
Portable Invasive
Blood Glucose
Monitoring Systems;
Availability |
|
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October 24, 2006 |
|
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FDA
Updates its
Nationwide Alert on
Counterfeit Blood
Glucose Test Strips
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|
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FTC
and FDA Act Against
Internet Vendors of
Fraudulent Diabetes
Cures and Treatments |
|
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October 23, 2006 |
|
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Draft
Guidance for
Industry and FDA
Staff - Total
Product Life Cycle
for Portable
Invasive Blood
Glucose Monitoring
Systems |
|
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CFR Changes - NONE
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Friday, Oct. 27, 2006 |
NONE
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Thursday, Oct. 26, 2006 |
NOTICES
Agency information
collection activities;
proposals, submissions, and
approvals,
62593–62594 [E6–17907]
[TEXT] [PDF]
Meetings:
Medical Devices Advisory Committee,
62594–62595 [E6–17932]
[TEXT] [PDF]
Pediatric Advisory Committee,
62595 [E6–17965]
[TEXT] [PDF]
Reports and guidance
documents; availability,
etc.:
Approved premarket approval applications; annual
reports,
62595–62597 [E6–17908]
[TEXT] [PDF]
|
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Wednesday, Oct. 25, 2006 |
PROPOSED RULES
Food for human consumption:
Food
labeling—
Conventional foods being
marketed as functional
foods; hearing,
62400–62407 [06–8895]
[TEXT] [PDF]
NOTICES
Food additive petitions:
Safe
Foods Corp.,
62475 [E6–17834]
[TEXT] [PDF]
|
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Tuesday, Oct. 24, 2006 |
NOTICES
Agency information
collection activities;
proposals, submissions, and
approvals,
62268 [E6–17718]
[TEXT] [PDF]
62268 [E6–17720]
[TEXT] [PDF]
Medical devices:
Premarket notification exemptions; Class II devices—
Cranial orthosis type devices,
62268–62269 [E6–17729]
[TEXT] [PDF]
Reports and guidance
documents; availability,
etc.:
Global Harmonization Task Force Study Groups; proposed
and final documents,
62269–62271 [E6–17727]
[TEXT] [PDF]
Portable invasive blood glucose monitoring systems;
total product life cycle,
62271–62272 [E6–17757]
[TEXT] [PDF]
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Monday, Oct. 23, 2006 |
NONE
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