Latest News Stock Watch Earnings Estimate Fundamentals Shareholder Reports Webcasts Regulatory Filings Corporate Governance Executive Team Affiliated Companies Press Room Analysts Request Investor Information Biovail, Depomed Announce Glumetza NDA Accepted by FDA TORONTO & MENLO PARK, Calif.--(BUSINESS WIRE)--June 24, 2004--Biovail Corporation (NYSE:BVF) (TSX:BVF) and Depomed, Inc.
Latest News Stock Watch Earnings Estimate Fundamentals Shareholder Reports Webcasts Regulatory Filings Corporate Governance Executive Team Affiliated Companies Press Room Analysts Request Investor Information Biovail Reports Second Quarter 2004 Financial Results TORONTO--(BUSINESS WIRE)--Aug.
Latest News Stock Watch Earnings Estimate Fundamentals Shareholder Reports Webcasts Regulatory Filings Corporate Governance Executive Team Affiliated Companies Press Room Analysts Request Investor Information Biovail and Depomed Announce Glumetza NDS Acceptance TORONTO & MENLO PARK, Calif.--(BUSINESS WIRE)--Aug.
Latest News Stock Watch Earnings Estimate Fundamentals Shareholder Reports Webcasts Regulatory Filings Corporate Governance Executive Team Affiliated Companies Press Room Analysts Request Investor Information Biovail, Depomed Receive Approvable Letter from FDA for Extended-Release Glumetza for Type II Diabetes TORONTO and MENLO PARK, Calif.--(BUSINESS WIRE)--March 1, 2005--Biovail...
Latest News Stock Watch Earnings Estimate Fundamentals Shareholder Reports Webcasts Regulatory Filings Corporate Governance Executive Team Affiliated Companies Press Room Analysts Request Investor Information Biovail, Depomed Announce Regulatory Approval of Glumetza to Treat Type II Diabetes in Canada TORONTO and MENLO PARK, Calif.--(BUSINESS WIRE)--June 1, 2005--Biovail Corporation (NYSE...
Latest News Stock Watch Earnings Estimate Fundamentals Shareholder Reports Webcasts Regulatory Filings Corporate Governance Executive Team Affiliated Companies Press Room Analysts Request Investor Information Biovail, Depomed Receive FDA Approval for Extended-Release Glumetza for Type II Diabetes; Enhanced Formulation to Offer Physicians Potential Advantages TORONTO and MENLO PARK, Calif.-...
Latest News Stock Watch Earnings Estimate Fundamentals Shareholder Reports Webcasts Regulatory Filings Corporate Governance Executive Team Affiliated Companies Press Room Analysts Request Investor Information Biovail Launches Glumetza to Canadian Physicians TORONTO, Nov 29, 2005 (BUSINESS WIRE) -- Biovail Corporation (NYSE:BVF)(TSX:BVF) announced today that it has officially launched...
Latest News Stock Watch Earnings Estimate Fundamentals Shareholder Reports Webcasts Regulatory Filings Corporate Governance Executive Team Affiliated Companies Press Room Analysts Request Investor Information Biovail and Depomed Submit NDA for Glumetza; Submission Includes 500mg and 1000mg dosages; Biovail/Depomed Expand Royalty Agreement to Include 1000mg dose TORONTO, Canada & MENLO PARK...
Latest News Stock Watch Earnings Estimate Fundamentals Shareholder Reports Webcasts Regulatory Filings Corporate Governance Executive Team Affiliated Companies Press Room Analysts Request Investor Information Biovail Reports 2004 First Quarter Financial Results TORONTO--(BUSINESS WIRE)--April 29, 2004--Biovail Corporation (NYSE:BVF) (TSX:BVF) announced today its financial results for the three...
Latest News Stock Watch Earnings Estimate Fundamentals Shareholder Reports Webcasts Regulatory Filings Corporate Governance Executive Team Affiliated Companies Press Room Analysts Request Investor Information 11/29/2005 8:32 AM Biovail Launches Glumetza to Canadian Physicians 11/16/2005 10:01 AM Biovail to Present at the CSFB 2005 Health Care Conference 11/15/2005 7:01 AM Biovail to Spin off...
Product Pipeline Stock Watch Earnings Estimate Fundamentals Shareholder Reports Webcasts Regulatory Filings Corporate Governance Executive Team Affiliated Companies Press Room Analysts Request Investor Information Biovail is working to develop clinically enhanced, branded versions of a number of existing in-market pharmaceutical compounds.
Microsoft PowerPoint - 1000 Biovail.ppt S., global markets – $15 billion (+ 9.6%) ° BPC: #1 independent pharmaceutical company in Canada – Proven track record of success ° Established, respected, 78- member sales force – Lean structure – high productivity per capita – Innovative, strategic marketing – Focused investment at top of the influence pyramid (specialists) ° Key...
author: ca1gcarasco
Microsoft PowerPoint - 1000 Biovail.ppt page 10
author: ca1gcarasco
http://www.barrlabs.com/overview/annual/BRL_AR2002.pdf Research and devel pment resulted in a rec rd number f new pr duct appr vals that expanded ur fferings in key therapeutic categ ries.
http://www.barrlabs.com/overview/annual/BRL_AR2002.pdf page 16
Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Releases 2004 - 2005: Teva Announces Approval Of Methylprednisolone Acetate Injectable Suspension Jerusalem, Israel, February 24, 2005 Teva and Lundbeck Announce European Approval for AZILECT® (rasagiline) 1mg for Parkinson's Disease Jerusalem, Israel and Copenhagen, Denmark, February 22, 2005 Teva Announces Settlement Of Lamictal® Litigation...
Teva Pharmaceutical Industries - News and PR Jerusalem, Israel and Tokyo, Japan, May 15, 2003 Teva Announces Approval of Moexipril HCl Tablets Jerusalem, Israel, May 8, 2003 Teva Announces Approval of Megestrol Acetate Oral Suspension Jerusalem, Israel, May 6, 2003 Teva Announces Settlement of Litigation with GSK on Nabumetone Jerusalem, Israel, April 30, 2003 Teva to Report First Quarter 2003 Financial Results on May 1, 2003...
Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Release Teva Announces Tentative Approval Of Metformin Hcl Extended Release Tablets, 750 Mg Jerusalem, Israel, December 14, 2004 - Teva Pharmaceutical Industries Ltd.Metformin Hydrochloride Extended Release Tablets, 750 mg.
Drug Approvals - A Activelle (estradiol/norethindrone acetate tablets), 1 mg/0.5 mg, Rx Novo Nordisk Pharmaceuticals NDA 20-907 11/18/98 11/18 11/18 7/8/99 Actonel (risedronate sodium) Tablet, Rx Procter & Gamble Pharmaceuticals NDA 20-835/S14 2/24/04 2/25/04 - - Actonel (risedronate sodium) Tablet, 35 mg, Rx Procter & Gamble Pharmaceuticals NDA 20-835/S8 & S9 5/17/02 5/23/02 - - Actonel (risedronate...
What's new at CDER in the last 30 days Food and Drug Administration • Center for Drug Evaluation and Research What's New by Category Search This page lists new and revised documents posted to the CDER web siteMetformin Hydrochloride Tablets for the treatment of type II diabetes
author: Paul Stauffer
What's new at CDER by Date Patent Term Extension and New Patents Docket Number *95S-0117 (updated) February 19, 2004 Colorectal Cancer Endpoints Workshop Summary FDA approves first-time generic Glyburide and Metformin Hydrochloride Tablets for the treatment of type II diabetesMetformin ...
author: Paul Stauffer
Prescription and Over-the-Counter Drug Product List: 1/2004 ADULT >A> + AAIPHARMA LLC 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL ;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL; 40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/V IAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL N21625 001 JAN 30, 2004 JAN NEWA BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED; TOPICAL BETAMETHASONE DIPROPIONATE >A> AB ATRIX EQ 0.05% BASE N76603 001 JAN 23, 2004 JAN NEWA BUPROPION HYDROCHLORIDE TABLET,...
Drug Approvals - M ANDA 75-586 5/30/02 - - - Metaproterenol Sulfate Inhalation Solution USP, 0.6%, Rx Novex Pharma ANDA 75-403 2/28/01 3/6/01 - - Metaproterenol Sulfate Inhalation Solution USP, 0.4%, Rx Novex Pharma ANDA 75-402 2/28/01 3/6/01 - - Metaproterenol Sulfate Syrup USP, 10 mg/5 mL, Rx Novex Pharma ANDA 75-235 1/27/00 2/4/00 - - Metaxalone Tablets, 400mg, Rx Tentative Approval CorePharma LLC...
Paragraph IV Patent Certifications - DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol...
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,...
