BioPortfolio Limited focus of concern shifts towards the UK 70 Market analysis: leading and new product sales to 2008 71 Wyeth 73 Premarin family (conjugated estrogens) 73 Novartis 79 Schering AG 79 Climara and Climara Pro (estradiol) 80 Avaden (estradiol/gestodene) 81 Solvay 82 Estratest (esterified estrogens/methyltestosterone) 82 Organon 83 Novo Nordisk 84 Outlook for the HRT...
http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
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...
NDA-I1: NDA Approval Letter page 1
author: CDER User
subject: NDA Approval Letter - Approval letter based on enclosed/submitted labeli\ ng text
http://www.phrma.org/newmedicines/resources/2003-09-02.117.pdf Triangle Park, NC (daily oral regimen) (973) 235- 5000 Roche Nutley, NJ prevention and treatment of Phase III postmenopausal osteoporosis (888) 825- 5249 (monthly oral dosing) (973) 235- 5000 prevention and treatment of Phase III postmenopausal osteoporosis (888) 825- 5249 (quarterly IV dosing) (973) 235- 5000 Climara Pro ® Berlex Laboratories osteoporosis...
http://www.phrma.org/newmedicines/resources/2003-09-02.117.pdf page 11
02-137 PhRMA NewMed OlderAm6/24 Triangle Park, NC (973) 235- 5000 Roche Nutley, NJ Climara Pro ® Berlex Laboratories osteoporosis in clinical trials estradiol and Montville, NJ levonorgestrel transdermal system Climarelle Berlex Laboratories osteoporosis in clinical trials 17ss estradiol Montville, NJ transdermal delivery system Forcaltonin ® Unigene Laboratories osteoporosis...
author: RL
02-137 PhRMA NewMed OlderAm6/24 page 10
author: RL
1998 Warning Letters and Untitled Letters to Pharmaceutical Companies DDMAC 6/25 6/29 Maxipime (Cefepime HCl) for Injection Bristol-Myers Squibb DDMAC 6/29 8/3 Mircette (Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol) Tablets Organon DDMAC 6/1 6/9 Naprelan (Naproxen Sodium) Tablets Wyeth-Ayerst DDMAC 6/8 6/29 Nasacort (Triamcinolone Acetonide) Rhone-Poulenc Rorer DDMAC 6/25 6/29 Nasonex (mometasone furoate monohydrate) nasal spray...
Products Aphabetical List - About Berlex | Contact Us | Feedback | Site Map | Search - Patients Healthcare Professionals Clinical Trials Home - Products Alphabetical Listing of Products Select a product name for more information ACUTECT® kit for the preparation of technetium to 99m depreotide injection BETAPACE® sotalol HCI BETAPACE AF® sotalol HCI BETASERON® interferon beta-1b CAMPATH®...
Select Berlex Milestones oral contraceptive market with LEVLEN®(levonorgestrel and ethinyl estrodiol tablets) and TRI-LEVLEN® (levonorgestrel and ethinyl estradiol tablets)CLIMARA ® (estradiol transdermal system), the first 7-day transdermal...
Press Release-Patient Education for those with MS - About Berlex | Contact Us | Feedback | Site Map | Search - Patients Healthcare Professionals Clinical Trials Home - Pressroom BERLEX ANNOUNCES EXECUTIVE APPOINTMENTS Montville, NJ, May 5, 2003 -- Reinhard Franzen, the new CEO of Berlex Laboratories, Inc., the US affiliate of Schering AG, Germany (NYSE:SHR), today announced appointments to his executive teamClimara ...
Feedback Check which products you use (check all that apply) * ACUTECT® (kit for the preparation of technetium tc 99m apcitide injection) BETASERON® (interferon beta-1b) BETAPACE® (sotalol HCI) BETAPACE AF™ (sotalol HCI) CAMPATH® (afemtuzumab) CLIMARA ® (estradiol transdermal system) FERIDEX I.V.® (ferumoxides injectable solution) FINEVIN™ (azelaic...
Prescription and Over-the-Counter Drug Product List: 6/2003 >D> AT ALLERGAN 1% N61187 001 JUN DISC >A> @ 1% N61187 001 JUN DISC >D> SOLUTION/DROPS; OPHTHALMIC >D> CHLOROPTIC >D> + ALLERGAN 0.5% N50091 001 JUN DISC >A> @ 0.5% N50091 001 JUN DISC >D> CHLOROQUINE HYDROCHLORIDE >D> INJECTABLE; INJECTION >D> ARALEN HCL >D> + SANOFI SYNTHELABO EQ 40MG BASE/ML N06002 002 JUN DISC >A> @ EQ 40MG BASE/ML N06002 002 JUN DISC CHLORPROMAZINE HYDROCHLORIDE...
author: AUTHOR
FDA Drug Approvals List April 2001 - Drug Approvals for April 2001 Definitions and Notes Original New Drug Applications Original Application #: 020949 Approval Date: 30-APR-01 Trade Name: ACCUNEB Chemical Type: 5 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: DEY LABORATORIES INC Active Ingredient(s): ALBUTEROL SULFATE OTC/RX Status: RX Indication(s): For the treatment of asthma-related bronchospasm in...
Prescription and OTC Drug Product List 2/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 2: February 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE CICLOPIROX TABLET; ORAL CREAM; TOPICAL LORTAB LOPROX - DLT - UCB 325MG;5MG N40099 001 - ADD - + AVENTIS PHARMS 0.77% N18748 001 - DLT - JUN 25, 1997 - ADD -...
Estrogen replacement therapy (ERT) - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Estrogen replacement therapy (ERT) - [Medication] - Quest Diagnostics Patient Health Library Estrogen replacement therapy (ERT) - [Medication] - Quest Diagnostics Patient Health Library Hormones, Sexual and reproductive organs, Sexual health, Women’s...
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
Pharmaceutical Research and Manufacturers of America - Osteoporosis Complete a new search Drug Name (Proprietary name/Generic name) Indications Addressed Click on indication to see all drugs for that indication Company Click a company to see all drugs for that company Development Status Notes 3339 SERM none / 3339 SERM Osteoporosis Aventis Pharmaceuticals Bridgewater, NJ Phase II - bazedoxifene none / bazedoxifene Osteoporosis Ligand...
http://www.schering.de/eng/investorrelationsforum/irpresentations/am_day_plus/pdfs/analystconf2002.pdf Analyst Meeting Berlin, March 1, 2002 ...
http://www.wyeth.com/news/pdf/2005_3Q.pdf This portfolio versatility should help us achieve close to double- digit revenue and earnings increases on a pro forma basis for the full year." "In addition, Wyeth's company- wide productivity initiatives are on track and moving forward on several fronts.levonorgestrel/ ...
http://www.wyeth.com/news/pdf/2005_2Q.pdf IMMEDIATE RELEASE Media Contact: Investor Relations Contact: Douglas Petkus Justin Victoria (973) 660- 5218 (973) 660- 5340 Wyeth Reports Earnings Results for the 2005 Second Quarter and First Half O Worldwide Net Revenue for the 2005 Second Quarter and First Half Increased 12% and 13% to $4.7 Billion and $9.3 Billion, Respectively, Driven by Core Products O Tygacil ™ ...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt 4134 31-Mar-81 MALLINCKRODT INC "GALLIUM CHL GA-67--MFGR AT MARYLAND HGTS., MISSOURI CYCLOTRON FACILITY" 4136 14-Apr-81 PERKINELMER LIFE SCIENCES "INDIUM-111 PRODUCED IN NORTH BILLERICA, MASS FACILITIES" 4139 27-Mar-81 SOCIETA ITALIANA MEDICINALI SCANDICCI (SIMS) LIDOCAINE BASE CRYSTALLIZED & LIDOCAINE HcL 4141 24-Mar-81 MAY AND BAKER LTD ACEBUTOLOL HCL/SECTRAL 4148 28-Apr-81 SOCIETA...
http://www.int-med.uiowa.edu/Intranet/Residents/xToDelete/GMedCurricOld/Jan-Jun%2004/Contraception/UTD-Oral.pdf Levonorgestrel - containing prel= larations may aggravate these problems, and should be avoided.
author: floerchingerd [ M68498 ]
http://www.fda.gov/cdrh/pdf2/P020014d.pdf Table 7 Pregnancy Rates for Temporary Birth Control method^^,^-^,* ;OB.^ I Iw1" ($ 1 I j i The Mowing table provides estimates of [he percent of wonieri likely to become pregnant while using a particular contraceptive method for 1 year These estimates are based on a variety of studies Hormonal Methods: Implant (Norplant" [levonorgestrel implants] 0.05% and Norplant" 2 [...
