CDERNEW-TEXT 11/1/2007
Thursday, November 1, 2007
November 1, 2007
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Adagen (pegademase bovine) Injection, Enzon Pharma, Labeling Revision
Bethanechol Chloride 5mg Tablets, Pharmax Group, Approval
Bethanechol Chloride 10mg Tablets, Pharmax Group, Approval
Bethanechol Chloride 25mg Tablets, Pharmax Group, Approval
Bethanechol Chloride 50mg Tablets, Pharmax Group, Approval
DDAVP Intranasal (desmopressin acetate), Sanofi-Aventis, Labeling
Revision
DDAVP Injection (desmopressin acetate) , Sanofi-Aventis, Labeling
Revision
DDAVP Tablets (desmopressin acetate) , Sanofi-Aventis, Labeling Revision
Tri-Legest-21 (Norethindrone Acetate and Ethinyl Estradiol) Tablets,
Barr Labs, Approval
Visken (pindolol) Tablets, Novartis Pharma, Labeling Revision
VIVITROL (naltrexone) Extended-release Injectable Suspension, Alkermes
Inc., Labeling Revision
Warning Letter: Site Inspection - Northeast General Pharmaceutical
Factory http://www.fda.gov/cder/warn/warn2007.htm#October
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posted by Mags @ 5:01 PM,
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CDERNEW-TEXT 10/31/2007
October 31, 2007
Drugs@FDA Downloadable Data Files
http://www.fda.gov/cder/drugsatfda/datafiles/default.htm
(updated)
FDA approves Tasigna (nilotinib) for the treatment of Philadelphia
chromosome positive chronic myeloid leukemia
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01734.html .
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Baclofen 10mg Tablets, Impax Labs, Approval
Baclofen 20mg Tablets, Impax Labs, Approval
Cetirizine Hydrochloride Syrup, Taro Pharma, Tentative Approval
Cetirizine Hydrochloride Tablets, Cipla Ltd., Tentative Approval
Fenofibrate Tablets, Par Pharma, Control Suppl.
Levocarnitine Oral Solution, P3 Labs, Approval
Symbicort (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol,
Astra Zeneca, Control Supp.
Requesting a Pre-Assigned Electronic Common Technical Document (eCTD)
Number from Office of Generic Drugs
http://www.fda.gov/cder/ogd/request_preassigned_ectd.htm
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posted by Mags @ 11:23 AM,
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CDERNEW-TEXT 10/29 & 30/2007
Wednesday, October 31, 2007
October 30, 2007
Guidance for Industry: Role of HIV Resistance Testing in Antiretroviral
Drug Development [PDF http://www.fda.gov/cder/guidance/7688fnl.pdf ]
Postmarketing Study Commitments Search
http://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm
(updated)
October 29, 2007
CellCept (mycophenolate mofetil)
http://www.fda.gov/medwatch/safety/2007/safety07.htm#CellCept2 - Changes
to prescribing information due to increased risk of first trimester
pregnancy loss and increased risk of congenital malformations.
Guidance for Industry: Acute Bacterial Sinusitis: Developing Drugs for
Treatment [PDF http://www.fda.gov/cder/guidance/3895dft.pdf ]
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Epirubicin Hydrochloride Injection, Watson Labs, Approval
Omeprazole Delayed-release Capsules 10 & 20mg, Apotex, Approval
Omeprazole Delayed-release Capsules 10 & 20mg, Impax Labs, Approval
Omeprazole Delayed-release Capsules 10 & 20mg, Dr. Reddy's Labs,
Approval
Renagel (sevelamer hydrochloride) Tablets, Genzyme Corp., Efficacy Supp.
w/Clinical Data
Renvela (sevelamer carbonate) Tablets, Genzyme Corp., Approval
Rivastigmine Tartrate Capsules, Sun Pharma, Approval
Stimate (desmopressin acetate) Nasal Spray, CSL Behring, Formulation
Revision
Tasigna Oral Capsule, Novartis, Approval
Valsartan Tablet, Ranbaxy Labs, Tentative Approval
Zithromax (azithromycin) 250mg Capsules, Pfizer, Labeling Revision
Zithromax (azithromycin) Single-Dose Packet, Pfizer, Labeling Revision
Zithromax (azithromycin) 600mg Tablet, Pfizer, Labeling Revision
Zithromax (azithromycin) Oral Suspension, Pfizer Inc., Labeling Revision
Zithromax (azithromycin) 250mg Tablet, Pfizer Inc., Labeling Revision
Zithromax (azithromycin) 500mg Tablet, Pfizer Inc., Labeling Revision
Zithromax IV (azithromycin) Injection, Pfizer, Labeling Revision
Zmax (azithromycin extended release) Oral Suspension, Labeling Revision
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posted by Mags @ 8:47 AM,
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