Baxter Launches First Sevoflurane in China and Announces Phased Launch in Other Countries in 2006 - - - Baxter Launches First Sevoflurane in China and Announces Phased Launch in Other Countries in 2006 - - With the Addition of Sevoflurane, Baxter Offers the Broadest Portfolio of Inhaled Anesthetics - DEERFIELD, Ill.Ultane ® (Abbott Laboratories).Sevoflurane package insert...
Pediatric Exclusivity Labeling Changes Food and Drug Administration • Center for Drug Evaluation and Research Pediatrics Search Pediatric Exclusivity Labeling Changes as of February 6, 2004 - - Exclusivity Granted (Labeled) Product Indications Label Changes 1Sevoflurane - Ultane (Abbott) Label [PDF ] Induction and maintenance of general anesthesia New study in pediatric patients 9...
Paragraph IV Patent Certifications - DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol...
http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA...
First-Time Generics - July 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - July 2002 Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG TEVA PHARMACEUTICALS USA PRINIZIDE TABLETS 7/1/02 2 LISINOPRIL TABLETS, USP 2.5 MG, 5 MG,--------...
author: OGD
CDER Report to the Nation: 2001 Food and Drug Administration • Center for Drug Evaluation and Research About CDER - Report Search CDER Report to the Nation: 2001 Table of Contents 1 Drug Review Index Mission Highlights New Drug Review Standard new drugs Priority new drugs New molecular entities Standard NMEs Priority NMEs Orphan drug approvals Notable 2001 new drug approvals New or Expanded Use Review...
author: OLIVERN
FDA Drug Approvals List August 2001 JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE Active Ingredient(s): COPPER OTC/RX Status: RX Application #:018612 Labeling Supplement#: 026 To Original New Drug Application Approval Date: 24-AUG-01 Trade Name: NICORETTE Dosage Form: GUM, CHEWING Applicant: SMITHKLINE BEECHAM CONSUMER HEALTHCARE LP Active Ingredient(s): NICOTINE POLACRILEX OTC/RX Status: RX Application #: 014879 Labeling...
Prescription and OTC Drug Product List 9/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST -A- ADEFOVIR DIPIVOXIL -A- TABLET; ORAL -A- HEPSERA -A- + GILEAD 10MG N21449 001 SEP 20, 2002 SEP NEWA ALBUTEROL SULFATE TABLET, EXTENDED RELEASE; ORAL -A- ALBUTEROL SULFATE -A- AB SIDMAK LABS EQ 4MG BASE N76130 002 SEP 26, 2002 SEP NEWA -A- AB EQ 8MG BASE N76130 003 SEP 26, 2002 SEP NEWA VOLMAX -D- BC + MURO EQ 4MG BASE N19604...
C:\NDAs\N20478(Ultane(sevoflurane)_Abbott)\S006AP.doc NDA 20- 478/ S- 006 Page 3 Note: Figures and tables are not included in this attachment
author: Lisa Basham
duplicates:http://www.fda.gov/cder/foi/label/2001/20478S6LBL.PDF
C:\NDAs\N20478(Ultane(sevoflurane)_Abbott)\S006AP.doc page 12
author: Lisa Basham
duplicates:http://www.fda.gov/cder/foi/label/2001/20478S6LBL.PDF http://www.fda.gov/cder/pediatric/labels/Sevoflurane.pdf
C:\NDAs\N20478(Ultane(sevoflurane)_Abbott)\S006AP.doc page 1
author: Lisa Basham
duplicates:http://www.fda.gov/cder/foi/label/2001/20478S6LBL.PDF http://www.fda.gov/cder/pediatric/labels/Sevoflurane.pdf
C:\NDAs\N20478(Ultane(sevoflurane)_Abbott)\S006AP.doc ULTANE Sevoflurane volatile liquid for inhalation DESCRIPTION ULTANE (sevoflurane), volatile liquid for inhalation, a nonflammable and nonexplosive liquid administered by vaporization, is a halogenated general inhalation anesthetic drug
author: Lisa Basham
Progress: Product Labeling with Significant Changes for Dosing or Risk Progress: Product Labeling with Significant Changes for Dosing or Risk Gabapentin (Neurontin): - adjunctive Rx in partial seizures - higher doses required in children less than 5 years of age in order to control seizures; new adverse events (e.g
The Federal Government: Recent changes at FDA and the Implications for Pediatric Clinical Trials 4%); serious bradycardia when propofol is concomitantly administered with fentanyl Sevoflurane (Ultane): induction and maintenance of general anesthesia - rare cases of seizures reported in children without a previous seizure history • Progress: Product Labeling with Significant Changes for Dosing or Risk Betamethasone (Diprolene AF): Corticosteroid responsive...
author: FDA.CDER
Product Labeling with Significant Changes for Dosing or Risk Product Labeling with Significant Changes for Dosing or Risk Gabapentin (Neurontin) - need to use higher doses in children less than five years of age in order to control seizures and new adverse events such as hostility and aggression identified in children less than 12 years Propofol (Diprivan) - increased mortality when used for pediatric ICU sedation (causality not determined);...
Progress: Product Labeling with Significant Changes for Dosing or Risk Progress: Product Labeling with Significant Changes for Dosing or Risk Gabapentin (Neurontin): -- adjunctive Rx in partial seizures - higher doses required in children less than 5 years of age in order to control seizures; new adverse events (e.g
Product Labeling with Significant Changes for Dosing or Risk Product Labeling with Significant Changes for Dosing or Risk Gabapentin (Neurontin) - need to use higher doses in children less than five years of age in order to control seizures and new adverse events such as hostility and aggression identified in children less than 12 years; Propofol (Diprivan) - increased mortality when used for pediatric ICU sedation; concomitant administration...
DDPA June 1995 DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE NDA NUMBER TRADE NAME APPLICANT ACTIVE INGREDIENT(S) APPROVAL DATE (DOSAGE FORM) STRENGTH(S) (CLASSIFICATION) CLASSIFICATION(S) ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20-132 IMITREX GLAXO WELLCOME SUMATRIPTAN SUCCINATE 01-JUN-95 (TABLET) RES TRIANGLE PK, NC EQ 25MG BASE (3 S) 27709 EQ 50MG BASE EQ...
Drug Approvals for December 1997 Also provides for the addition of Haemophilus influenzae to the presently approved indication for secondary bacterial infections of acute bronchitis Application #: 020522 Efficacy Supplement#: 004 Type: SE1 to Original New Drug Application Approval Date: 17-DEC-97 Trade Name: NUTROPIN AQ Dosage Form: INJECTABLE Applicant: GENENTECH INC Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC...
Patient Safety Web Portal FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH Mission Statement: To continuously inform and educate health care professionals on patient safety issues as related to medical devices, by providing a convenient mechanism in which to access current and emerging issues within the Federal domain
author: OSB
CDER: Previous News Items 2003 FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - Previous News Items 2003 Previous News Items 2004 Previous News Items 2002 December 30, 2003 The prescribing information for Topamax (topiramate/topiramate capsules) has been revised to include a warning that Topamax causes hyperchloremic, non-anion gap metabolic acidosis (decreased serum...
Anesthetic and Life Support Drugs Advisory Committee Meetings FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - Anesthetic and Life Support Drugs Advisory Committee Meetings List of Tentative Meeting Dates for All CDER Advisory Committees List of Committee Members Committee Charter CDER Contacts -Current Year Meeting Information 2004 FDA Advisory Committee Calendar -Meeting information includes center...
Patent and Exclusivity Terms I-391 ABLATION OF HIGH-GRADE DYSPLASIA IN BARRETT'S ESOPHAGUS PATIENTS WHO DO NOT UNDERGO ESOPHAGECTOMY I-392 TX OF PED PATIENTS W/PH+ CHRONIC PHASE CML DISEASE RECUR AFTER STEM CELL TRNSPLT OR RESIST TO INTERFERON ALPHA THERAPY.NO CONTROLLED TRIALS DEMONSTRATING A CLINICAL BENEFIT SUCH AS IMPROVE IN DISEASE RELATED SX OR INCREASED SURVIVAL I-393 CHRONIC BACTERIAL PROSTATITIS I-394...
1997 Warning Letters and Notice of Violation Letters to Pharmaceutical Companies Food and Drug Administration • Center for Drug Evaluation and Research Compliance Activities Search Warning Letters and Untitled Letters to Pharmaceutical Companies 1997 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office
Reference Listed Drug Labeling Approved in August 2001 Aug 1 LOTRIMIN AF letter letter letter -- clotrimazole cream clotrimazole lotion clotrimazole topical solution 20-888 20-889 20-890 S-002 S-002 S-002 Aug 2 SINGULAIR SINGULAIR CHEWABLE letter label montelukast sodium tablets 20-829 20-830 S-012 S-014 Aug 6 LUPRON DEPOT-PED letter - leuprolide acetate for depot suspension 20-263 S-017 VONTROL letter - diphenidol tablets 16-033 S-011...
author: USERNAME
