BIOPHARMA FDA Approvals for the treatment of HIV patients with wasting or cachexia [upgraded from accelerated approval granted in 1996] Factor VIII, rDNA, PFM [Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method - Advate; Factor VIII, recombinant; rAHF-PFM] - granted on 7/25/2003 to Baxter Hyland Immuno for treatment of hemophilia A.Iprivask; ...
http://www.fda.gov/cder/orange/appendix_a.txt ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
NDA Approvals for Calendar Year 2003 NDA APPROVALS FOR CALENDAR YEAR 2003 Updated through December 31, 2003 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21434 Xanax XR Alprazolam Pharmacia and Upjohn FR 3 S 17-Jan-03 21305 Sodium Iodide I-131 Sodium Iodide I-131 DraxImage 3,5 S 24-Jan-03 20414 Pyridostigmine Bromide Pyridostigmine Bromide US Army 3 P 05-Feb-03...
author: Susan Daugherty
Prescription and Over-the-Counter Drug Product List: 4/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL FIORICET -D- AB + NOVARTIS 325MG;50MG;40MG N88616 001 NOV 09, 1984 APR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG N88616 001 NOV 09, 1984 APR CAHN ACYCLOVIR CAPSULE; ORAL ACYCLOVIR -A- AB AAIPHARMA 200MG N74833 001 APR 22, 1997 APR CAHN -D- AB AESGEN 200MG N74833 001 APR 22, 1997...
author: AUTHOR
C:\Data\My Documents\21271-Iprivask\AP-letter.doc NDA 21- 271 Page 3 Iprivask 15 mg [Desirudin for Injection] Rx only SPINAL/ E URAL HEMATOMAS When neuraxial anesthesia (epidural/ spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with selective inhibitors of thrombin such as Iprivask may be at risk of developing an epidural or spinal hematoma which can...
author: Alice Kacuba
C:\Data\My Documents\21271-Iprivask\AP-letter.doc page 15
author: Alice Kacuba
C:\Data\My Documents\21271-Iprivask\AP-letter.doc page 14
author: Alice Kacuba
C:\Data\My Documents\21271-Iprivask\AP-letter.doc page 13
author: Alice Kacuba
C:\Data\My Documents\21271-Iprivask\AP-letter.doc page 12
author: Alice Kacuba
C:\Data\My Documents\21271-Iprivask\AP-letter.doc page 11
author: Alice Kacuba
C:\Data\My Documents\21271-Iprivask\AP-letter.doc page 10
author: Alice Kacuba
C:\Data\My Documents\21271-Iprivask\AP-letter.doc page 9
author: Alice Kacuba
C:\Data\My Documents\21271-Iprivask\AP-letter.doc page 8
author: Alice Kacuba
C:\Data\My Documents\21271-Iprivask\AP-letter.doc page 7
author: Alice Kacuba
C:\Data\My Documents\21271-Iprivask\AP-letter.doc page 6
author: Alice Kacuba
C:\Data\My Documents\21271-Iprivask\AP-letter.doc page 4
author: Alice Kacuba
C:\Data\My Documents\21271-Iprivask\AP-letter.doc page 2
author: Alice Kacuba
C:\Data\My Documents\21271-Iprivask\AP-letter.doc page 1
author: Alice Kacuba
