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http://www.biosis.org/ts/media/cdjournals/gazettenews/2004/CPG_News_0404.pdf
www.current-patents.com ISSN:1464-3499 The records appearing in this Gazette will be added to DOLPHIN, the Database Of alL PHarmeceutical INventions.
This week sees the announcement of a UK SPC application covering Abbott’s paricalcitol.
This application is based on Wisconsin Alumni Research Foundation’s EP387077 and, if granted, we estimate would give the...
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Drug Approvals - Z
Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted ZADITOR (ketotifen fumarate ophthalmic solution) 0.025%, Rx Ciba Vision NDA 21-066 7/2/99 7/6/99 7/6/99 3/31/02 ZADITOR (ketotifen fumarate ophthalmic solution) 0.025%, Rx Ciba Vision NDA 21-066/S4 07/20/01 05/08/03 - ZADITOR Indication: for the prevention of itching of the eye due to allergic...
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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,...
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20819_Zemplar.htm
Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Zemplar (Paricalcitol) Injection Company:- Abbott Laboratories Application No.:- 20-819 Approval Date:-4/17/1998 - Approval Letter(s) - Medical Review(s) - Part 1 - Part 2 - Part 3 - Part 4 - Part 5 - Chemistry Review(s) -- Pharmacology Review(s) Part 1 - Part 2 - Part 3 -...
author: Paul Stauffer
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Abbott to spin-off hospital products business
Abbott will retain the following proprietary pharmaceuticals, including related portions of the international hospital business: hospital operating room pharmaceuticals, such as Ultane/Sevorane (sevoflurane), Anzemet (dolasetron mesylate injection) and proprietary neuromuscular blockers; hospital pharmaceuticals such as Calcijex (calcitriol injection), Zemplar (paricalcitol...
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FDA Drug Approvals List February 2000
- Drug Approvals for February 2000 Definitions and Notes Original New Drug Applications Original Application #: 021015 Approval Date: 28-FEB-00 Trade Name: ANDROGEL Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: UNIMED PHARMACEUTICALS INC Active Ingredient(s): TESTOSTERONE OTC/RX Status: RX Indication(s): For replacement therapy in males for conditions...
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C:\labeling\zemplars07ap.doc
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 20- 819/ S- 007, S- 011 Abbott Laboratories Attn: Mary O'Sullivan D- 389, Bldg
O'Sullivan: Please refer to your supplemental new drug applications dated April 14, 2000 (S- 007) and February 13, 2002 (S- 011), received April 17, 2000 (S- 007) and February 14, 2002 (S-...
author: Kati Johnson
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C:\labeling\zemplars07ap.doc page 1
author: Kati Johnson
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Zemplar Consumer Information
Zemplar® Brand Name: Zemplar® Active Ingredient: - paricalcitol Strength(s): 5mcg/ml Dosage Form(s): - Injection Company Name: -- Abbott Laboratories Availability: ------- Prescription only *Dated Approved by FDA: - April 17, 1998 *Approval by FDA does not mean that the drug is available for consumers at this time
Zemplar is used to prevent and...
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FDA Drug Approvals List- April 1998
Original Application #: 020846 Approval Date: 29-APR-98 Trade Name: LAMISIL Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): TERBINAFINE OTC/RX Status: RX Indication(s): Topical treatment of the following dermatologic infections: tinea (pityriasis) versicolor due to Malassezia furfur (formerly Pityrosporum ovale...
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EFFICACY SUPPLEMENTS APPROVED IN CY 2000
EFFICACY SUPPLEMENTS APPROVED IN CY 2000 GENERIC NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPP TYPE SUPP NUMBER PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION IBUPROFEN WHITEHALL ROBINS 20-812 15-Jun-98 12-Jan-00 SE5 003 N 18.9 Provides for the use of Infants' Advil (ibuprofen oral suspension) Concentrated Oral Drops, 50 mg/1.25 mL for ages 6 months...
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FDA Drug Approvals List September 2000
PEDIATRIC Dosage Form: INJECTABLE Applicant: ASTRAZENECA LP Active Ingredient(s): ASCORBIC ACID; VITAMIN A; ERGOCALCIFEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; DEXPANTHENOL; VITAMIN E; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; PHYTONADIONE; NIACINAMIDE OTC/RX Status: RX Application #: 050679 Labeling Supplement#: 013 To Original New Drug...
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http://www.fda.gov/cder/ogd/rld/20819s4.PDF
Koehler: Please refer to your supplemental new drug application dated June 9, 1999, received June 10, 1999, submitted under section 505( b) of the Federal Food, Drug, and Cosmetic Act for Zemplar (pancalcitol injection)
Director Division of Metabolic and Endocrine Drug Products Office of Drug Evaluation II Center for Drug Evaluation and Research Zemplar TM (...
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http://www.fda.gov/cder/ogd/rld/20819s4.PDF page 3
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http://www.fda.gov/cder/foi/label/2000/20819S3LBL.PDF
Zemplar™ (paricalcitol injection) Fliptop Vial DESCRIPTION Zemplar™ (paricalcitol injection) is a synthetically manufactured vitamin D analog
Phosphate or vitamin D- related compounds should not be taken concomitantly with Zemplar™
Digitalis toxicity is potentiated by hypercalcemia of any cause, so caution should be applied when...
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http://www.fda.gov/cder/foi/label/2000/20819S3LBL.PDF page 6
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http://www.fda.gov/cder/foi/label/2000/20819S3LBL.PDF page 5
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http://www.fda.gov/cder/foi/label/2000/20819S3LBL.PDF page 4
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http://www.fda.gov/cder/foi/label/2000/20819S3LBL.PDF page 2
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http://www.fda.gov/cder/foi/label/2000/20819S3LBL.PDF page 1
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http://www.fda.gov/cder/foi/appletter/2000/20819S3LTR.PDF
NDA 20- 819/ S- 003 Abbott Laboratories Attention: Ms
Leslie Koehler Manager Regulatory Affairs 200 Abbott Park Road D389, Building AP30 Abbott Park, IL 60064- 6154 Dear Ms
Koehler: Please refer to your supplemental new drug application dated March 29, 1999, received April 2, 1999, submitted under section 505( b) of the Federal Food, Drug, and Cosmetic Act for Zemplar (...
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http://www.fda.gov/cder/foi/appletter/2000/20819S3LTR.PDF page 1
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http://www.biotechnav.com/1-04NewsColorBlank.pdf
1 The investment report that gives you the essentials to wisely invest in biotechnology securities
Celgene's lead product, Thalomid, was featured in over 50 abstracts at ASH that highlighted its use as monotherapy or in combination with other agents for newly diagnosed and relapsed/ refractory MM patients
More importantly, the two compounds have a better safety profile than...
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http://www.biotechnav.com/1-04NewsColorBlank.pdf page 8
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