Columbia Laboratories, Inc. The makers of Prochive 8% (progesterone gel), Prochieve 4% (progesterone gel), RepHresh and
Unterberg, Towbin Specialty Pharmaceuticals Conference - 08/24/04 - Edward Blechschmidt and Stephen Kasnet Elected to Columbia Laboratories Board of Directors - 08/16/04 -Kronos Longevity Research Institute (KLRI) Changes Protocol for HRT Study - 08/04/04 - Columbia Laboratories Reports Second Quarter 2004 Financial Results - 08/03/04 - PUBLISHED PHASE III STUDY SHOWS STRIANT ®...
BioPortfolio Limited
5.17 Implantable Insulin Pumps 5.18 Insulin Pills 5.19 Transdermal Insulin 5.20 Oral Spray Insulin00-2005 5.21 Inhaled Insulin 5.22 Numerous Potential Blockbusting Diabetes Products Set to Arrive 2005-2007 5.23 Exubera: The Wait Continues 5.24 Oralin: Liquid Aerosol Insulin 5.25 Hexyl-Insulin Monoconjugate (HIM2) 'Nowhere Near Phase III' 5.26 AERx iDMS Earlier Market Launch Expected...
IROA - Scientific Study Reference Search
Pellets 2-Acetamidofluorene (2-AAF) 2-Acetylaminofluorene (AAF) 2-OHE1 3,3',5-Triiodo-L-Thyronine (T3) 4-Hydroxyandrostene-3,17-dione (4-OHA) 4-Hydroxyandrostenedione 5a-Androstan-3a + 17ss-diol 5a-Dihydrotestosterone (5a-DHT) 5a-Dihydrotestosterone (5a-DHT) 5a-Reductase Inhibitor (4MA) 5-Bromo-2'-Deoxyurdine (BrDU) 5a-Dihydrotestosterone (5a-DHT) 6-n-Propyl-2-Thiouracil (PTU...
Press Release for July 28, 2004
News Contact: Amy Raskopf, Manager, Investor Relations - (973) 994-3999 x.7925 - - COLUMBIA LABORATORIES REPORTS POSITIVE RESULTS OF -PREGNANCY RATE PILOT STUDY WITH PROCHIEVE ® 8% - Use of Prochieve 8% and Estradiol with Clomiphene Citrate More Than Doubled Pregnancy Rates versus Clomiphene Citrate Alone - LIVINGSTON, NJ - July 28, 2004 - Columbia...
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...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE5TEXT.txt
5414 18-Jun-84 SERONO LABORATORIES INC BIOEQUIVALENCE STUDIES FOR THREE CLOMIPHENE CITRATE PRODUCTS 5516 27-Aug-84 MORGAN ADHESIVES CO PRESSURE SENSITIVE ADHESIVE SUBSTRATES MFG MOOSIC PA 5767 27-Mar-85 STERIS-ISOMEDIX SERVICES "CONTRACT STERILIZATION FACILITY IN SANDY, UTAH." 5821 29-Apr-85 STERIS-ISOMEDIX SERVICES "CONTRACT STERILIZATION FACILITY IN WHIPPANY, NJ" 5829...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE5EXCEL.xls
Arthur Shaw CDER User $ ($) $ ($) $ ($) $ ($) $ $ () $ - () - $ $ () $ - () - -- -- $ ($) $ ($) $ ($) $ ($) / / // -- - - : : :: : () () () () () - $ $ () $ - () - $ $ () $ - : :: : 4Q2003 ALLEXCEL DMF # Type SUBMIT DATE HOLDER SUBJECT V CIBA SPECIALTY CHEMICALS CORPORATION TRICLOSAN TOXICOLOGY INFORMATION V PHARMACIA AND UPJOHN INC STERILE MANUFACTURING FACILITY IN CLAYTON NC V...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
LISINOPRIL CRUDE AS MFG IN COURBEVOIE AND HAM FRANCE 14537 19-Nov-99 FUJISAWA PHARMACEUTICAL CO LTD FK8453 DRUG SUBSTANCE AS MFG IN HYOGO AND OSAKA JAPAN 14538 09-Nov-99 SICOR DE MEXICO SA DE CV AMCINONIDE AS MFG IN LERMA MEXICO 14539 18-Nov-99 "UQUIFA ITALIA, S.P.A." CLINDAMYCIN HYDROCHLORIDE USP AS MFG IN MILAN ITALY 14540 18-Nov-99 DIOSYNTH BV TESTOSTERONE UNDECANOATE AS MFG IN...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
AVENTIS PHARMA SA HYDROCORTISONE HEMISUCCINATE ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV ERTHROMYCIN PHOSPHATE ORGAMOL SA BUPIVACAINE HCL AVENTIS PHARMA SA 6-ALPHA-METHYLPREDNISOLONE HEMISUCCINATE PROCOS SPA PHENYLTOLOXAMINE CITRATE PROCOS SPA ORPHENADRINE HYROCHLORIDE & ORPHENADRINE CITRATE BASF CORP POVIDONE-IODINE LEK PHARMACEUTICALS D.D THEOPHYLLINE,...
http://www.repromed.com.au/DOCUMENTS/statement.pdf
Information Statement Table of Contents i Welcome to 1 Out of Hours Contact 1 Legal Aspe 2 Health and 4 Counselling and Support 5 Medications 6 Ovulation 8 Intra Uterine Insemination 10 Donor Sperm Program (DI) 12 IVF, ICSI Treatment 13 § How many eggs to be Inseminated Limit on Number of Embryos The licensee is not permitted by law to place more than three embryos in a woman...
Prescription and OTC Drug Product List 8/1999
Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 8: August 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE AZATHIOPRINE SODIUM CAPSULE; ORAL INJECTABLE; INJECTION FEMCET IMURAN - DLT - AB MALLINCKRODT 325MG;50MG;40MG N89102 001 - ADD - AP + FARO PHARMS EQ 100MG BASE...
SLT Clinical Procedure Rreview by Dr. Thomas Lyons, MD FACOG
Treatment modes have shifted significantly from surgical to medical by using ovulation induction agents such as Clomiphene Citrate, gonadotropin therapy, and most recently, gonadotropin releasing hormone agonists followed by induction of ovulation Each of the patients had been tried on a regimen of Clomiphene Citrate 50-100mg for 5-7 days beginning on day 2...
FDA Drug Approvals List August 1999
Approvable Original New Drug Applications Original Application #: 021037 Approvable Date: 26-AUG-99 Trade Name: MAGNEVIST Dosage Form: INJECTABLE Applicant: BERLEX LABORATORIES INC Active Ingredient(s): GADOPENTETATE DIMEGLUMINE OTC/RX Status: RX Original Application #: 020989 Approvable Date: 27-AUG-99 Trade Name: EVOXAC Dosage Form: CAPSULE Applicant: SNOWBRAND PHARMACEUTICALS INC...
http://www.fda.gov/cder/foi/appletter/1999/75528ltr.pdf
ANDA 75- 528 August 30, 1999 Par Pharmaceutical, Inc Attention: Michelle Bonomi- Huvala One Ram Ridge Road Spring Valley, NY 10977 Dear Madam: This is in reference to your abbreviated new drug application dated December 17, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Clomiphene Citrate Tablets USP, 50 mg Reference is...
http://www.fda.gov/cder/foi/appletter/1999/75528ltr.pdf page 1
DDPA October 1995
***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 18-482 PROCARDIA PFIZER LABS NIFEDIPINE 04-OCT-95 (CAPSULE) NEW YORK, NY 10MG 10017 20MG (LABELING REVISION -- DESCRIPTION; CLINICAL PHARMACOLOGY; WARNINGS; PRECAUTIONS; ADVERSE REACTIONS; OVERDOSAGE) 19-386 BREVIBLOC OHMEDA PHARM ESMOLOL HYDROCHLORIDE 04-OCT-95 (INJECTABLE) LIBERTY CORNER, NJ 10MG/ML 07938 250MG/ML (LABELING REVISION --...
Problems With Sperm: Infertility: Merck Manual Home Edition
Section Women's Health Issues Subject Infertility Problems With Sperm To be fertile, a man must be able to deliver an adequate quantity of normal sperm to a woman's vagina, and sperm must be able to fertilize the egg. Genetic disorders involve an abnormality of the sex chromosomes, as occurs in Klinefelter syndrome. Occasionally, semen, which contains the sperm, moves in the...
Problems With Ovulation: Infertility: Merck Manual Home Edition
Section Women's Health Issues Subject Infertility Problems With Ovulation In women, a common cause of infertility is an ovulation problem—that is, the ovaries do not release an egg each month (see Biology of the Female Reproductive System: Menstrual Cycle ). Ovulation may not occur because the hypothalamus does not secrete gonadotropin-releasing hormone, which stimulates the...
Problems With Sperm: Infertility: Merck Manual Home Edition
Search Recent Searches Index Sections A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
Problems With Ovulation: Infertility: Merck Manual Home Edition
Search Recent Searches Index Sections A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
Index: CL: Merck Manual Home Edition
Search Recent Searches Index Sections A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
THE MERCK MANUAL, Sec. 19, Ch. 269, Endocrine And Metabolic Disorders
This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 19. These patients present a clinical picture similar to that of bilateral cryptorchidism, except that there is no rise in circulating testosterone after human chorionic gonadotropin (hCG) injections. In addition to an abnormal semen analysis, serum follicle-stimulating hormone (FSH) may be...
THE MERCK MANUAL, Sec. 18, Ch. 235, Menstrual Abnormalities And Abnormal Uterine Bleeding
This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 18. 275 ) must always be considered in childhood bleeding and can usually be recognized by the development of secondary sexual characteristics. 241 ). Adenomyosis (benign invasion of endometrium into the myometrium) is a common disorder that causes symptoms in only a small percentage of...
THE MERCK MANUAL, Sec. 18, Ch. 235, Menstrual Abnormalities And Abnormal Uterine Bleeding
This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 18. Chronic anovulation is the most common form of amenorrhea among women of reproductive age who are not pregnant. The polycystic ovary syndrome (sometimes termed hyperandrogenic chronic anovulation) is a benign disorder. Galactorrhea (nonpuerperal secretion of milk) may occur. Abnormal...
THE MERCK MANUAL, Sec. 18, Ch. 245, Infertility
This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 18. A nadir in temperature suggests impending ovulation; an increase of >= 0.5° C (>= 0.9° F) characterizes the postovulatory period. For this diagnosis to be established, delay should occur in two menstrual cycles. Polycystic ovary syndrome or chronic anovulation: ...