BIOPHARMA FDA Approvals Somatropin, rDNA/Serono [Somatropin (rDNA origin) - Serostim; human growth hormone, recombinant] - full approval granted on 8/29/2003 to Serono Inc.Recombinant), Plasma/Albumin Free Method - Advate;...
Approved Products_2004.xls Number A pproval Date Trade Name Generic/ Chemical name Indication Company 1 Oct- 82 Humulin Human Insulin Type I Diabetes Lilly / Genentech 2 Oct- 85 Protro pin Human Growth Hormone Hypoptuitary dwarfism Genentech 3 Jun- 86 Intron A Interferon Al pha 2B Hairy Cell Leukemia Schering Plough / Biogen 4 Jun- 86 OKT- 3 Anti CD3 Mab Acute Trans plant Rejection JNJ / OrthoBiotech 5 Jun- 86...
author: Reijer
Prescription and Over-the-Counter Drug Product List: 1/2004 ADULT >A> + AAIPHARMA LLC 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL ;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL; 40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/V IAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL N21625 001 JAN 30, 2004 JAN NEWA BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED; TOPICAL BETAMETHASONE DIPROPIONATE >A> AB ATRIX EQ 0.05% BASE N76603 001 JAN 23, 2004 JAN NEWA BUPROPION HYDROCHLORIDE TABLET, EXTENDED...
http://www.fda.gov/cder/orange/appendix_a.txt 2, BUTABARBITAL SODIUM SARISOL, BUTABARBITAL SODIUM APPENDIX A PRODUCT NAME INDEX SATRIC, METRONIDAZOLE SCABENE, LINDANE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCLEROSOL, TALC SCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENE SEASONALE, ETHINYL ESTRADIOL SECOBARBITAL SODIUM, SECOBARBITAL SODIUM SECONAL SODIUM, SECOBARBITAL SODIUM SECREFLO, SECRETIN...
Prescription and Over-the-Counter Drug Product List: 11/2003 ACTHAR GEL >D> BC + QUESTCOR PHARMS 80 UNITS/ML N08372 008 NOV CTEC >A> + 80 UNITS/ML N08372 008 NOV CTEC CYTARABINE INJECTABLE; INJECTION >D> CYTARABINE >D> AP + GENSIA SICOR PHARMS 100MG/VIAL N16793 001 NOV DISC >D> AP + 500MG/VIAL N16793 002 NOV DISC >D> AP + 1GM/VIAL N16793 003 DEC 21, 1987 NOV DISC >D> AP + 2GM/VIAL N16793 004 DEC 21, 1987 NOV DISC >A> @ SICOR PHARMS 100MG/VIAL...
Approved Biotechnology Drugs, 2002 - Acutely decompensated congestive heart failure with shortness of breath at rest or with minimal activity - Aug 2001 Neulasta™ (pegfilgrastim) - Amgen - Reduction of incidence of infection as manifested by febrile neutropenia in non-myeloid cancer patients receiving certain chemotherapies - Jan 2002 Neumega® (oprelvekin) - Wyeth - Prevention of severe chemotherapy-induced...
C:\Data\Serono\20604s027apltr.doc NDA 20- 604/ S- 027 Page 2 Serostim ® [somatropin (rDNA origin) for injection] Rx Only BX Rated DESCRIPTION Serostim ® [somatropin (rDNA origin) for injection] is a human growth hormone (hGH) produced by recombinant DNA technologySerostim ® [somatropin (rDNA...
author: Monika Johnson
FDA Drug Approvals List September 2001 - Drug Approvals for September 2001 Definitions and Notes Original New Drug Applications Original Application #: 021279 Approval Date: 25-SEP-01 Trade Name: FORADIL Chemical Type: 3 Therapeutic Potential: S Dosage Form: POWDER, FOR INHALATION Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): FORMOTEROL FUMARATE OTC/RX Status: RX Indication(s): For the long-term, twice...
FDA Drug Approvals List June 2001 PERRIGO COMPANY Active Ingredient(s): MONOXIDIL OTC/RX Status: RX Original Abbreviated Application # 075750 Approval Date: 8-JUN-01 Trade Name: DOXAZOSIN MESYLATE Dosage Form: TABLET Applicant: SIDMAK LABORATORIES, INC Active Ingredient(s): DOXAZOSIN MESYLATE OTC/RX Status: RX Original Abbreviated Application # 075502 Approval Date: 05-JUN-01 Trade Name: CLOTRIMAZOLE AND...
Prescription and OTC Drug Product List 11/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 325MG;5MG N40478 001 NOV 08, 2002 NOV NEWA -A- AA 500MG;10MG N40473 001 NOV 06, 2002 NOV NEWA -A- AA 500MG;5MG N40477 001 NOV 06, 2002 NOV NEWA AMCINONIDE LOTION; TOPICAL -A- AMCINONIDE -A- AB ALTANA 0.1% N76329 001 NOV 06, 2002 NOV NEWA CYCLOCORT -D- + FUJISAWA...
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...
Prescription and OTC Drug Product List 6/2002 -D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE/10ML N21238...
FDA Drug Approvals List April 2000 Approvable Original New Drug Applications Original Abbreviated New Drug Applications Original Abbreviated Application # 074657 Approval Date: 28-APR-00 Trade Name: TERAZOSIN HCL Dosage Form: TABLET Applicant: INVAMED INC Active Ingredient(s): TERAZOSIN HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application# 065041 Approval Date: 28-APR-00 Trade Name: DOXYCYCLINE...
http://www.fda.gov/cder/foi/label/2001/20604s14lbl.pdf Serostim ® [somatropin (rDNA origin) for injection] DESCRIPTION Serostim ® [somatropin (rDNA origin) for injection] is a human growth hormone produced by recombinant DNA technologySerostim ® [somatropin (rDNA origin) for injection] is an anabolic and anticatabolic agent which exerts its influence by...
http://www.fda.gov/cder/foi/label/2001/20604s14lbl.pdf page 4
http://www.phrma.org/newmedicines/resources/bio00.pdf page 31
http://www.phrma.org/newmedicines/resources/bio00.pdf page 20
FDA Drug Approvals List October 2000 - Drug Approvals for October 2000 Definitions and Notes Original New Drug Applications Original Application #: 020958 Approval Date: 16-OCT-00 Trade Name: PEPCID COMPLETE Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET, CHEWABLE Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC Active Ingredient(s): CALCIUM CARBONATE, PRECIPITATED; FAMOTIDINE; MAGNESIUM HYDROXIDE...
FDA Drug Approvals List July 2000 - Drug Approvals for July 2000 Definitions and Notes Original New Drug Applications Original Application #: 050779 Approval Date: 27-JUL-00 Trade Name: CEFAZOLIN AND DEXTROSE Chemical Type: 5 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: B BRAUN MEDICAL INC Active Ingredient(s): CEFAZOLIN SODIUM OTC/RX Status: RX Indication(s): For the treatment of respiratory tract...
http://www.fda.gov/cder/ogd/rld/20604s10.PDF e., a "Dear Health Care Practitioner" letter) is issued to physicians and others responsible for patient care, we Serostim ® DESCRIPTION Serostim ® [somatropin (rDNA origin) for injection] is a human growth hormone produced by recombinant DNA technologySerostim ® [somatropin (rDNA origin) for injection] therapy...
http://www.fda.gov/cder/ogd/rld/20604s10.PDF page 6
http://www.fda.gov/cder/ogd/rld/20604s9.pdf page 3
DDPA August 1996 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 19-640 HUMATROPE LILLY SOMATROPIN, BIOSYNTHETIC 01-AUG-96 (INJECTABLE) INDIANAPOLIS, IN 5MG/VIAL (SUPPL-013) 45285 (NEW INDICATION...
BioPortfolio Limited 39 Chapter 2 Erythropoietins 44 Summary 44 Class overview 44 Mechanism of action 46 Global sales 46 Analysis of leading products 47 Procrit/Eprex (epoetin alpha) 47 Epogen (epoetin alpha) and Aranesp (darbepoetin alpha) 50 NeoRecormon/Epogin (epoetin beta) 52 Late stage R&D activity 53 Hemolink (hemoglobin raffimer) 54 Chapter 3 Interferons 56 Summary 56 Class overview 57 Mechanism...
Endocrinologic and Metabolic Drugs Advisory Committee Meetings FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - Endocrinologic and Metabolic 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...
