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,
