Drug Approvals - O Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Ocufen Ophthalmic Solution, (0.03%) Allergan NDA 19-404/S020 8/25/03 8/28/03 8/28/03 - Ocufen Ophthalmic Solution (0.03%) Allergan NDA 19-404/S017 8/17/01 - 4/15/03 - Ocufen Ophthalmic Solution (0.03%) Allergan NDA 19-404/S014 7/30/01 - 4/15/03 - Ofloxacin Injection, 40 mg/mL packaged in 10 mL...
http://www.fda.gov/cder/orange/appendix_a.txt IRRIGANT, NEOMYCIN SULFATE NEOSPORIN, BACITRACIN ZINC NEOSPORIN, GRAMICIDIN NEOSPORIN, NEOMYCIN SULFATE (OTC) NEOTHYLLINE, DYPHYLLINE NEOTRIZINE, TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE; SULFAMETHAZINE) NEPHRAMINE 5.4%, AMINO ACIDS NEPHROFLOW, IODOHIPPURATE SODIUM, I-123 NEPTAZANE, METHAZOLAMIDE NESACAINE, CHLOROPROCAINE HYDROCHLORIDE NESACAINE-MPF, CHLOROPROCAINE...
21-232_ORFADIN Capsules Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Orfadin (Nitisinone) Capsules Company:--R&R Registrations U.S
author: Paul Stauffer
CDER 2002 Report to the Nation; Drug Review Food and Drug Administration • Center for Drug Evaluation and Research About CDER - Report Search CDER Report to the Nation: 2002 Table of Contents Adobe Acrobat version of this document 1 Drug Review Index Mission Highlights New Drug Review List of priority new drugs List of new molecular entities List of orphan new drugs New Drug Review Statistics Priority new drug statistics...
author: OLIVERN
NMEs Approved in CY 2002 NMEs Approved in Calendar Year 2002 - NDA Number Generic Name Trade Name Dosage Form Applicant *Classification Approval Date 21-232 Nitisinone Orfadin Capsule Swedish Orphan -- 1PV 01-18-2002 21-286 Olmesartan Medoxomil Benicar Tablet Sankyo- 1S 04-25-2002 21-344 Fulvestrant Faslodex Injection AstraZeneca 1S 04-25-2002 21-272 Treprostinil Sodium Remodulin Injection United...
author: Susan Daugherty
Fast Track Designated Products Approved since 1998 FAST TRACK DESIGNATED PRODUCTS APPROVED SINCE 1998 Through September 30, 2003 - NDA# NDA Drug Name Sponsor Applicant Approval Date Indication N020972 Sustiva (Efavirenz) 50/ 100/ 200MG Caps Dupont Pharms 9/17/98 Treatment of HIV N20977 Ziagen (Abacavir Sulfate) Tablets Glaxo Wellcome 12/17/98 Treatment of HIV N20978 Ziagen (Abacavir Sulfate) Oral Solution 12/17/98 N21007 Agenerase ...
author: Michael Lanthier
Prescription and OTC Drug Product List 5/2002 2 -D- + ROBINS AH 325MG;15MG N84444 001 MAY DISC -A- @ 325MG;15MG N84444 001 MAY DISC SOLUTION; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -D- AA ALPHARMA 120MG/5ML;12MG/5ML N85861 001 MAY CRLD -A- AA + 120MG/5ML;12MG/5ML N85861 001 MAY CRLD TYLENOL W/ CODEINE -D- AA + JOHNSON RW 120MG/5ML;12MG/5ML N85057 001 MAY DISC -A- @ 120MG/5ML;12MG/5ML N85057 001 MAY DISC TABLET; ORAL...
Prescription and OTC Drug Product List 1/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA KV PHARM 500MG/15ML;7.5MG/15ML N40366 001 JAN 23, 2002 JAN NEWA AMPHOTERICIN B INJECTABLE, LI COMPLEX; INJECTION ABELCET -A- + ELAN PHARMS 5MG/ML N50724 001 NOV 20, 1995 JAN CAHN -D- + LIPOSOME 5MG/ML N50724 001 NOV 20, 1995 JAN...
C:\WINDOWS\Desktop\Orfadin\AP-LTR.doc Fumarylacetoacetate HT- 1 hydrolyase (FAH) defect Fumarate + acetoacetate Heme synthesis Mechanism of Action of Nitisinone Nitisinone is a competitive inhibitor of 4- hydroxyphenyl- pyruvate dioxygenase, an enzyme upstream of FAH in the tyrosine catabolic pathway (see FigNitisinone was biotransformed in rats and excreted via the urineNitisinone, 1 mg/...
author: Samuel Wu
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author: Samuel Wu
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author: Samuel Wu
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author: Samuel Wu
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author: Samuel Wu
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author: Samuel Wu
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author: Samuel Wu
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author: Samuel Wu
Contents Vol. 3, No. 2, 2002 Contents Original Research Articles Tolterodine: Selectivity for the Urinary Bladder Over the Eye (as Measured by Visual Accommodation ) in Healthy Volunteers 75- 81 CR Chapple, L Nilvebrant Adis R& D Profiles: Oxybutynin Intravesical Situs, S- Oxybutynin 82- 85 Efficacy of N- Acetylcarnosine in the Treatment of Cataracts 87- 103 MA Babizhayev, AI Deyev, VN Yermakova, YA Semiletov,...
author: Adis International Limited
subject: Drugs in R&D
http://www.adis.com/files/newsletters/INP/Icov1324.pdf CANCER Bexarotene + interferon- in cutaneous T- cell lymphoma 12 Capecitabine + docetaxel in breast cancer 15 Docetaxel + capecitabine in breast cancer 15 Gemcitabine + paclitaxel in transitional cell cancer 10 Imatinib mesylate: additional indication approved in the US 22 Interferon- (natural) approved in Mexico 22 Interferon- + bexarotene in cutaneous T- cell lymphoma 12 Letrozole...
COMP Press Release 9th meeting Press Release The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 13 E- mail: mail@ emea. eudra. org http:// www. eudra. org/ emea. html 18 January 2001 COMP/ 16/ 01 corr. ...
author: COMP
subject: Press Release
COMP Press Release 9th meeting page 3 Press Release COMP/ 16/ 01 3/ 6 ANNEX I to COMP January 2001 Press Release Medicinal products Designated as Orphan Medicinal Products since the December 2000 Press Release Active substance Thalidomide Sponsor Laboratoires Laphal Orphan Indication Treatment of Erythema nodosum leprosum (ENL) or type II lepra ...
author: COMP
subject: Press Release
