CDERNEW-TEXT 9/20/2007
Friday, September 21, 2007
September 20, 2007
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Ciclopirox Topical Solution, Synerx Pharma, Approval
Ciclopirox Topical Solution, Hi-Tech Pharmacal, Approval
Ciclopirox Topical Solution, Teva Pharma, Approval
Ciclopirox Topical Solution, G & W Labs, Approval
Ciclopirox Topical Solution, Taro Pharma, Approval
Ciclopirox Topical Solution, Watson Labs, Approval
Ciclopirox Topical Solution, Perrigo Co., Approval
Ciclopirox Topical Solution, Tolmar Inc., Approval
Ciclopirox Topical Solution, Apotex, Approval
Ciclopirox Topical Solution, Actavis, Approval
Colgate Total (sodium fluoride and triclosan dentifrice paste),
Colgate-Palmolive, Manufacturing Change or Addition
Kionex (Sodium Polystyrene Sulfonate) Suspension, Paddock Labs, Approval
MEFOXIN (cefoxitin sodium) Injection, Merck & Co., Labeling Revision
OsmoPrep (sodium phosphate monobasic monohydrate & sodium phosphate
dibasic anhydrous) Tablets, Salix Pharma, Labeling Revision
Ranitidine Syrup, Apotex, Approval
VANCOCIN HCL (vancomycin) Injection, Baxter Healthcare, Labeling
Revision
Warning Letter: Site Inspection, Kunshan Chemical & Pharmaceutical
Company http://www.fda.gov/cder/warn/warn2007.htm#September
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posted by Mags @ 10:10 AM,
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CDERNEW-TEXT 9/18/2007
Wednesday, September 19, 2007
September 18, 2007
Approved Active Moieties That Have Appeared On The National Institutes
Of Health's (NIH) Annual Priority List For Which FDA Has Issued A
Written Request For Pediatric Studies Under The Best Pharmaceuticals For
Children Act (BPCA) http://www.fda.gov/cder/pediatric/offpatwrlist.htm
(updated)
FDA launches the first issue of the FDA Drug Safety Newsletter
http://www.fda.gov/cder/dsn/default.htm , a publication for healthcare
professionals and the medical community.
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
CEFZIL (cefprozil) Tablets, Bristol-Myers Squibb, Labeling Revision
CEFZIL (cefprozil) Oral Suspension, Bristol-Myers Squibb, Labeling
Revision
Evista (raloxifene hydrochloride) Tablets, Eli Lilly, Approval
Gleevec (imatinib mesylate) Ttablets, Novartis Pharma, Efficacy Suppl.
w/Clinical Data
Imodium Advance (loperamide HCl and simethicone) Caplets, McNeil
Consumer, Formulation Revision
Lamotrigine Tablets, Zydus Pharma, Tentative Approval
Macrodantin (nitrofurantoin macrocrystals) Capsules, Proctor and Gamble,
Labeling Revision
MAXIPIME (cefepime hydrochloride) Powder for Injection, Bristol-Myers
Squibb, Labeling Revision
OMNICEF (cefdinir) Capsules, Abbott Labs, Labeling Revision
OMNICEF (cefdinir) Oral Suspension, Abbott Labs, Labeling Revision
SOMA (carisoprodol) Tablets, Medpointe Pharma, New Dosage Regimen
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posted by Mags @ 1:12 PM,
,
CDERNEW-TEXT 9/17/2007
Tuesday, September 18, 2007
September 17, 2007
Drug Shortage; Drug to be Discontinued; Ethmozine (moricizine
hydrochloride) 200mg, 250g, and 300mg tablets
http://www.fda.gov/cder/drug/shortages/default.htm#Ethmozine (updated)
FDA issues an Alert on the risk of QT prolongation and Torsades de
Pointes (TdP) in patients treated with Haldol (haloperidol). Drug
Information http://www.fda.gov/cder/drug/InfoSheets/HCP/haloperidol.htm
New PDUFA payment procedures for application and supplement fees
effective October 1, 2007
http://www.fda.gov/cder/pdufa/application_fees.htm#new
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posted by Mags @ 2:04 PM,
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