Herpes Simplex Virus Infections: Viral Infections: Merck Manual Home Edition
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Database D
D - investigational drugs, therapies and vaccines # - 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 From this page you may order documents with information covering investigational products. See Humira (2913) D4E1 (Peptidyl MIM) (1134) DAB389IL-2. See DN1924 - (2900) DAPD (Amdoxovir) (1668). Further product...
Database A
A - investigational drugs, therapies and vaccines # - 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 From this page you may order documents with information covering investigational products. See SAIK-MS (2806) Abraxane (ABI-007, Paclitaxel Albumin Stabilized Nanopartice Formulated) (2824) Abreva * (...
Microsoft PowerPoint - Issue 4-04.ppt
Neurodex Asthma/ Allergy Abreva ® THE WAY WE THINK ABOUT DRUG DEVELOPMENT Welcome to the Avanir Pharmaceuticals newsletter Also in this issue is a preview of an interview with our CEO conducted by The Wall Street Transcript to be published in conjunction with an upcoming investor conference com Neurodex Asthma/ Allergy Abreva ® Avanir Conference Schedule The...
author: mcruse
Microsoft PowerPoint - Issue 4-04.ppt page 2
author: mcruse
http://www.fda.gov/cder/orange/appendix_a.txt
APPENDIX A PRODUCT NAME INDEX ** 0 ** 0, AMOXICILLIN ** 8 ** 8-HOUR BAYER, ASPIRIN (OTC) 8-MOP, METHOXSALEN ** A ** A-HYDROCORT, HYDROCORTISONE SODIUM SUCCINATE A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE A-N STANNOUS AGGREGATED ALBUMIN, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT A-POXIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE A.P.L., GONADOTROPIN, CHORIONIC A/T/S, ERYTHROMYCIN ABELCET,...
20-941_Abreva.htm
Food and Drug Administration Center for Drug Evaluation and Research Approval Package Search Abreva (Docosanol) Cream Company:- Avanir Pharmaceuticals Application No.:- 20-941 Approval Date:-7/25/2000 - Approval Letter(s) - Printed Labeling - Medical Review(s)- Part 1 - Part 2 - Chemistry Review(s) - Pharmacology Review(s) Part 1 - Part 2 - Statistical Review(s) -...
author: Paul Stauffer
http://www.phrma.org/newmedicines/resources/2003-11-23.120.pdf
T o combat the one of the world's most devastating diseases, pharmaceutical and biotechnology researchers are testing 83 medicines for HIV/ AIDS and related conditions, intensifying their efforts and achieving steady progress in the development of vaccines Triangle Park, NC 9 M E D I C I N E S I N D E V E L O P M E N T F O R HIV/ AIDS 2003 APPROVED MEDICINES FOR AIDS- RELATED...
http://www.phrma.org/newmedicines/resources/2003-11-23.120.pdf page 10
Approved Biotechnology Drugs, 2002
Biotechnology Information, Advocacy and Business Support | About Us | BIO Events | BIO Members | Join BIO | Member Services | Links | Home CMS Payment System Prescription Coverage & Reimbursement Food & Agriculture Industrial & Environmental Bioethics & Biomedical Research Intellectual Property Regulatory Policies Tax & Fiscal Policies All Issues & Initiatives Press Releases Company...
Report to the Nation: Drug Review
Priority new drug approvals (N=NME) Abacavir/lamivudine/zidovudine (Trizivir) Alosetron (Lotronex) (N) Arsenic trioxide (Trisenox) (N) Atovaquone/proquanil (Malarone) Bexarotene (Targetin) Budesonide (Pulmicort) Didanosine (Videx EC) Gentuzumab ozogamicin (Mylotarg) (N) Levobetaxolol (Betaxon) Levofloxacin (Quixin) Linezolid (Zyvox) (3 NDAs approved, 1 as NME) (N) Lopinavir/ritonavir...
author: OLIVERN
NMEs Approved in CY 2000
NMEs Approved in Calendar Year 2000 NDA Number Generic Name- Trade Name Dosage Form Applicant - --- Classification- Approval Date 20-989 Cevimeline HCl Evoxac Capsule Snowbrand 1S 01-11-2000 21-014 Oxcarbazepine Trileptal Tablet Novartis Pharms 1S 01-14-2000 20-987 Pantoprazole Sodium Protonix Tablet Wyeth Ayerst 1S 02-02-2000 21-107 Alosetron HC1 Lotronex Tablet Glaxo Wellcome 1P 02...
author: Susan Daugherty
http://www.phrma.org/newmedicines/resources/2002-12-05.98.pdf
P harmaceutical and biotechnology companies continue to research new and more effective ways to treat and prevent HIV/ AIDS, which affects an estimated 40 million people worldwide and has caused nearly half a million deaths in the United States alone Triangle Park, NC APPROVED MEDICINES FOR AIDS- RELATED CONDITIONS Product Name Company Indication ABELCET ® The Liposome...
http://www.phrma.org/newmedicines/resources/2002-12-05.98.pdf page 10
BIO Editors &Reporters 03LIVE page 53
author: Elinor
http://www.phrma.org/newmedicines/resources/2001-01-10.11.pdf
I n 2000, pharmaceutical and biotechnology companies received approval for 27 new drugs and 6 new biologics Food and Drug Administration Total number of new drugs approved in each year 30 35 27 23 30 28 53 39 25 22 26 New Drug Approvals in 2000 NDA DA Review oreign Product ompany Indication/ Use Received Approved Time Availability* Abreva AVANIR topical treatment for 12/ 22/...
http://www.phrma.org/newmedicines/resources/2001-01-10.11.pdf page 2
01-310 NewMeds AIDS Final copy
A s the war against AIDS enters its third decade, pharmaceutical companies are continuing to research new weapons to thwart this persistent and deadly enemy Triangle Park, NC APPROVED MEDICINES FOR AIDS- RELATED CONDITIONS Product Name Company Indication ABELCET ® The Liposome Company treatment of severe systemic fungal infections in patients amphotericin B Princeton, NJ...
author: RL
01-310 NewMeds AIDS Final copy page 11
author: RL
00-322 NewMeds AIDS REV 11/17
2000 AIDS N E W M E D I C I N E S I N D E V E L O P M E N T F O R Survey P R E S E N T E D B Y A M E R I C A' S P H A R M A C E U T I C A L C O M P A N I E S P harmaceutical companies are working on the next generation of medicines for AIDS, while continuing to improve existing treatments and medicines for AIDS- related conditions, according to a new survey by the Pharmaceutical...
author: RL
00-322 NewMeds AIDS REV 11/17 page 9
author: RL
00-354 2000 PhRMA NDA 01/17
I n 2000, pharmaceutical and biotechnology companies received approval for 27 new drugs and 6 new biologics Food and Drug Administration Total number of new drugs approved in each year 30 35 27 23 30 28 53 39 25 22 26 ¬ New Drug Approvals in 2000 NDA FDA Review Foreign Product Company Indication/Use Received Approved Time Availability* Abreva ª AVANIR topical...
author: RL
00-354 2000 PhRMA NDA 01/17 page 2
author: RL
December 17, 2001
BioCenturyPart II VOL The companies plan to begin by year end a pexelizumab Phase III trial in patients undergoing coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB) Business: Infectious diseases AVN received a $5 million milestone from North American marketing partner GSK related to sales of its Abreva docosanol 10% cream, an over- the-...
author: BioCentury Publications Inc.
subject: BioCentury
December 17, 2001 page 3
author: BioCentury Publications Inc.
subject: BioCentury