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U.S. Newswire - Americans Taking the High Blood Pressure Drug Cardizem(r) CD May Benefit from Major Class Action Settlement

admin — Fri, 02 Jan 2009 10:51:03 +0000

WASHINGTON, Aug. 13 /U.S. Newswire/ — Hypertension patients and
others who took the medication Cardizem(r) CD or its generic
equivalents between 1998-2003 may be entitled to money from a $21
million fund created as part of a proposed settlement of a nationwide
antitrust lawsuit brought by the Attorneys General of all 50 states,
Puerto Rico and the District of Columbia.

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Cardizem in CanadaCardizem settlementBiovail to market CardizemThose Cardizem Cd ads…Teva launches generic version of Cardizem CD

The case alleges that the
drug makers violated antitrust laws and overcharged consumers
purchasing Cardizem(r) CD or its generic equivalents. Defendants
have denied any wrongdoing or liability. A nationwide effort to
contact …

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Pharma Marketletter - Biovail gets US approval for long-acting Cardizem LA; launch in April.

admin — Sun, 28 Dec 2008 06:16:02 +0000

Canada’s Biovail has achieved a significant milestone with the US approval of Cardizem LA (diltiazem), the first drug developed under a New Drug Application that the company will launch directly to physicians. Cardizem LA is a graded-release formulation of the calcium channel blocker that provides 24-hour control of blood pressure in patients …

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Cardizem in CanadaCardizem settlementBiovail to market CardizemThose Cardizem Cd ads…Teva launches generic version of Cardizem CD

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Drug Store News - Teva launches generic version of Cardizem CD

admin — Thu, 25 Dec 2008 20:51:02 +0000

Teva will launch Diltiazem Extended Release Capsules (once-a-day) in all dosage strengths. Diltiazem ER is the generic equivalent of Aventis’ (formerly Hoechst) Cardizem CD, which is indicated for the treatment of hypertension and angina. Sales of Cardizem CD in the. United States for the 12 months ended June 30 exceeded $650 million, Teva said.

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Biovail Corp. had earlier received FDA approval for the generic Cardizem CD. Teva has exclusive marketing rights from Biovail for the United States.
COPYRIGHT 2000 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2008 Gale, Cengage Learning

Drug Store News - Biovail to market Cardizem

admin — Sun, 21 Dec 2008 03:11:02 +0000

Biovail Corp. has purchased the rights to market the Cardizem line of calcium channel blockers in North America from Aventis. Biovail will pay Aventis $409.5 million. Aventis will continue to manufacture the Cardizem line.
The Cardizem product line includes Cardizem CD (diltiazem) for hypertension and angina pectoris, Cardizem SR sustained-release capsules for hypertension and Cardizem tablets for angina, as well as Cardizem injectable, Cardizem monovial and Cardizem lyo-ject syringe, all for treatment of atrial fibrillation.

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Cardizem in CanadaCardizem settlementThose Cardizem Cd ads…Teva launches generic version of Cardizem CDAndrx’ Cardizem CD Launched in Canada

Biovail said it plans to add up to 500 sales representatives from its current 300. The U.S. sales force will focus on expanding prescriptions for existing products. It will also begin marketing Cardizem XL, which is expected to be launched in the first half of 2002.
COPYRIGHT 2001 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2008 Gale, Cengage Learning

Nursing Law's Regan Report - Punitive damage award of $5 million reduced.

admin — Sun, 14 Dec 2008 05:46:03 +0000

WHEN THE CONDUCT OF HEALTH CARE PROVIDERS IS SO OUTRAGEOUS AND CLEARLY CONTRARY TO APPLICABLE STANDARDS OF CARE, PUNITIVE DAMAGES CAN BE AWARDED. Often, there is a direct correlation between the amount of punitive damages awarded and the extent to which the conduct is outrageous and violative of applicable standards of care. That was the situation in this unusual case in which a patient was perceived by a jury to have been battered from pillar to post by a total failure to comply with basic standards of applicable nursing care!

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Indiana Consumers Will Share in Settlement over Blood-Pressure Medication.

Biovail Files Cardizem LA NDA for Angina.

ON FRIDAY, JUNE 4, 1999, LIDA TYLER, 72, COMPLAINED …

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Business Wire - Biovail Reports 2003 Fourth Quarter and Full Year Financial Results

admin — Mon, 08 Dec 2008 16:46:02 +0000

Business Editors/Health/Medical Writers
TORONTO–(BUSINESS WIRE)–March 3, 2004
Biovail Corporation (NYSE:BVF) (TSX:BVF):
— Core Product sales revenue increases by 59%
— Core Product Revenue $172 million for 2003 versus $108 million
for 2002
— Biovail Pharmaceuticals Canada Product Revenue $85 million for
2003 versus $33 million for 2002
— Wellbutrin XL Revenue $65 million for 2003
— Legacy Product Revenue $209 million for 2003 versus $324
million for 2002
— Generic Product Revenue $101 million for 2003 versus $182
million for 2002
— Slides to facilitate the earnings call may be accessed at
www.biovail.com
Biovail Corporation (NYSE:BVF) (TSX:BVF) announced today its financial results for the three and twelve month periods ending December 31, 2003. Total revenues for the three months ended December 31, 2003 were $199.7 million versus $238.7 million for the three months ended December 31, 2002. Total revenues for the twelve months ended December 31, 2003 were $823.7 million representing an increase of 5% versus $788.0 million for the prior year.
Total revenues for fourth quarter 2003 were favourably impacted versus fourth quarter 2002 total revenues by the launches of Cardizem LA, Teveten HCT, Zovirax Cream and Wellbutrin XL in 2003, as well as an increase in products sales by the Company’s Canadian division due to the acquisition of Wellbutrin SR and Zyban. Fourth quarter 2003 total revenue versus fourth quarter 2002 total revenues were offset by lower revenue of the Company’s Zovirax, Legacy and Generic product lines, as well as lower research and development revenue and co-promotion, royalty and licensing revenue.
Full year 2003 total revenues versus 2002 total revenues were favourably impacted by the product launches described above and the Company’s Canadian division, as well as by higher royalty revenue related to an interest in the gross margins of a generic omeprazole product. This increase in 2003 total revenue was partially offset by lower product sales revenue of the Company’s Legacy and Generic product lines.
Eugene Melnyk, Chairman of the Board and Chief Executive Officer commented, “2003 was a year of transition for Biovail as we made significant progress towards a fully-integrated pharmaceutical company and started to invest strategically for long-term growth in our operations, sales and marketing areas. First half 2004 will be a period of investment as we continue to expand and specialize our sales force in the U.S. and capitalize on our products and pipeline by balancing conservative returns on investment with necessary investments for growth. 2005 will be a year of superior financial results whereby the benefits of 2004 strategic investing is expected to deliver on long-term objectives for growth and profitability. These results will be seen in new product launches, increased sales throughout the U.S. and simultaneously developing our rapidly maturing pipeline of high value products.”
In accordance with U.S. GAAP, fourth quarter 2003 net loss of $96.0 million and diluted loss per share of $0.60 compared to fourth quarter 2002 net loss of $102.8 million and diluted loss per share of $0.65. In accordance with U.S. GAAP, the twelve-month period ended December 31, 2003 net loss was $27.3 million and diluted loss per share was $0.17 compared to net income of $87.8 million and earnings per share of $0.55 for the twelve-month period ended December 31, 2002. The Company had diluted shares outstanding of 159.3 million and 159.9 million for fourth quarter and full year 2003 respectively compared to 158.1 million and 160.5 million for the fourth quarter and full year 2002 respectively.
In the fourth quarter of 2003, Biovail reduced its provision for tax contingencies by $12.0 million that were no longer required due to the resolution of tax uncertainties and incremental tax loses in the U.S.
2003 Financial Performance
Biovail uses five categories to describe its product sales revenue thereby providing financial clarity and ease in monitoring Biovail’s performance. These categories are as follows:

Core Products — includes Cardizem LA, Zovirax products and
Teveten products

Wellbutrin XL — identified as a separate line for ease in
tracking

Biovail Pharmaceuticals Canada (BPC) — including Tiazac,
Wellbutrin SR and Zyban

Legacy Products — includes Tiazac (brand and generic), Cardizem
CD (brand) Ativan/Isordil, Vasotec/Vaseretic, Rondec and Cedax

Generics — controlled-release generics distributed by Teva
Pharmaceuticals

Product Sales Performance
Product sales revenue for the fourth quarter 2003 were $168.3 million compared to $183.8 million in the fourth quarter of 2002, reflecting a decrease of 8%. Product sales revenue were $632.9 million for the year 2003 compared to $646.0 million for the year 2002, reflecting a decrease of 2%. Fourth quarter 2003 product sales revenue was decreased by a $20.0 million increase in the provision for returns.

Business Wire - Andrx Announces ANDA Filing for Cardizem LA

admin — Thu, 04 Dec 2008 08:26:03 +0000

FORT LAUDERDALE, Fla. — Andrx Corporation (Nasdaq:ADRX) (”Andrx” or “Company”) today announced that it has a pending abbreviated new drug application (”ANDA”) with the United States Food and Drug Administration (”FDA”) for generic versions of Cardizem(R) LA (diltiazem HCl extended-release tablets), 120mg, 180mg, 240mg, 300mg, 360mg and 420mg strengths. Andrx initially filed its ANDA for the 420mg strength on April 25, 2005, with a Paragraph IV certification and notification to the patent holder. On August 10, 2005, Biovail Laboratories Int’l SRL. (”Biovail”), which is the holder of the New Drug Application for Cardizem LA, initiated a patent infringement lawsuit against the Company for the 420mg strength in the U.S. District Court for the District of Delaware. On August 30, 2005, Andrx amended its initial ANDA submission to include the 120mg, 180mg, 240mg, 300mg and 360mg strengths, along with a related Paragraph IV certification and notice letter. On October 14, 2005, Biovail initiated a patent infringement lawsuit on the remaining strengths. Andrx believes that it may have been the first ANDA applicant with a Paragraph IV certification for each of the six strengths, and accordingly may be entitled to 180 days of market exclusivity under the Hatch Waxman Amendments.

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According to IMS data, U.S. sales of Cardizem LA, which is now marketed by Kos Pharmaceuticals, Inc., for the trailing 12 months ended June 2005, were approximately $85 million.
About Andrx Corporation
We are a pharmaceutical company that:
–develops, manufactures and commercializes generic versions of controlled-release, niche and immediate-release pharmaceutical products, including oral contraceptives;
–distributes pharmaceuticals, primarily generics, which have been commercialized by others, as well as our own, primarily to independent pharmacies, pharmacy chains and physicians’ offices; and
–develops and manufactures pharmaceutical products for other pharmaceutical companies, including combination products and controlled-release formulations utilizing our patented technologies and formulation capabilities.
Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein or which are otherwise made by or on behalf of the Company that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “to,” “plan,” “expect,” “believe,” “anticipate,” “intend,” “could,” “would,” “estimate,” or “continue” or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risk and uncertainties, including but not limited to: what sanctions, if any, FDA may seek, following its decision to place Andrx in OAI (Official Action Indicated) status, and when the “hold” on the Company’s ANDA approvals will be lifted, the timing and ability to obtain FDA approval of the Company’s Cardizem LA ANDA, whether such ANDA is entitled to the 180-day exclusivity period, and the timing and outcome of litigation related thereto, the Company’s dependence on a relatively small number of products, licensing revenues, the timing and outcome of litigation and future product launches, government regulation, competition, manufacturing capacities, safety issues, output and quality processes, recent management appointments and changes and the potential loss of senior management and other key personnel. We are also subject to other risks detailed herein or detailed from time to time in our Annual Report on Form 10-K for the year ended December 31, 2004, or in our other SEC filings. Subsequent written and oral forward-looking statements attributable to us or to persons acting on our behalf are expressly qualified in their entirety by the cautionary statements set forth in our Annual Report on Form 10-K for the year ended December 31, 2004, and in our other SEC filings.
This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com.
COPYRIGHT 2005 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning

Business Wire - Andrx’ Cardizem CD Launched in Canada

admin — Fri, 28 Nov 2008 02:01:02 +0000

Business Editors/Health & Medical Writers
FORT LAUDERDALE, Fla.–(BUSINESS WIRE)–March 12, 2001
Andrx Corporation — Andrx Group (Nasdaq:ADRX) today announced that Health Canada, the Canadian health authority, has approved the sale throughout Canada of all four strengths of its bioequivalent version of Cardizem(R) CD. Licensed to Rhoxalpharma, Inc., this product, marketed as Rhoxal-diltiazem CD, has already been launched. Diltiazem CD remains one of the largest selling pharmaceuticals in Canada, with over U.S. $60 million in sales in 2000.
Andrx President, Elliot F. Hahn, Ph.D., said, “We are pleased that our first product will be available internationally.”

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Biovail Files Cardizem LA NDA for Angina.

Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained in this report that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “to,” “expect,” “believe,” “anticipate,” “intend,” “could,” “would,” “estimate,” or “continue” or the negative or other variations thereof or comparable terminology are intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risk and uncertainties. Andrx Group is a class of common stock of Andrx Corporation, therefore Andrx Corporation shareholders are subject to the risks and uncertainties described in Andrx Corporation’s filings with the Securities and Exchange Commission, including Andrx Corporation’s Annual Report on Form 10-K for the year ended December 31, 1999.
This release and additional information about Andrx Corporation are also available at http://www.andrx.com.
COPYRIGHT 2001 Business Wire
COPYRIGHT 2001 Gale Group

M2 Presswire - In- Depth Research on Biovail Corp.

admin — Mon, 24 Nov 2008 14:51:02 +0000

M2 PRESSWIRE-3 April 2007-Biotech News: In- Depth Research on Biovail Corp(C)1994-2007 M2 COMMUNICATIONS LTD RDATE:03042007 In- Depth Research on Biovail Corp (NYSE:BVF) Biovail Corporation engages in the formulation, clinical testing, registration, manufacture, and commercialization of pharmaceutical products utilizing various drug-delivery technologies in the United States and Canada.

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Biovail Files Cardizem LA NDA for Angina.

The company principally focuses on central nervous system disorders, pain management, and cardiovascular diseases. It offers Zovirax Cream, an antiviral medication, for the treatment of herpes …

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M2 Presswire - Andrx claims exclusive generic marketing rights for Cardizem LA high blood pressure drug: TTMT, ONCY, ADRX, BVF, ABT.

admin — Sat, 22 Nov 2008 05:41:03 +0000

M2 PRESSWIRE-20 October 2005-SessionsIR.com: Andrx claims exclusive generic marketing rights for Cardizem LA high blood pressure drug: TTMT, ONCY, ADRX, BVF, ABT(C)1994-2005 M2 COMMUNICATIONS LTD RDATE:20102005 Stocks in the News: Tiger Team Technologies Incorporated (OTC: TTMT), Oncolytics Biotech Incorporated (NASDAQ: ONCY), Andrx Corporation (NASDAQ: ADRX), Biovail Corporation (NYSE: BVF), Abbott Laboratories Incorporated (NYSE: ABT) For Corporate or Company information in regards to SessionsIR, please visit: www.sessionsir.com or contact us at: info@sessionsir.com.

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