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Biovail's Supplemental NDS For TIAZAC XC Accepted For Review by Therapeutic Products Directorate in Canada.


TORONTO -- Biovail Corporation (NYSE NYSE

See: New York Stock Exchange
:BVF BVF Biovail Corporation (stock symbol)
BVF Berufsverband der Frauenärzte eV (Muenchen, Germany)
BVF Bearing Versus Frequency
)(TSX:BVF) announced today that the company's supplemental New Drug Submission (sNDS) for TIAZAC(R) XC, a once-daily extended-release formulation of diltiazem hydrochloride, for the treatment of angina, has been accepted for review by the Therapeutic Products Directorate Therapeutic Products Directorate (TPD) is a Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, a role performed by the Food and Drug Administration in the United States.  (TPD).

In August 2004, TIAZAC(R) XC, which is available in 120mg-360mg dosages, received TPD approval for the treatment of hypertension. TIAZAC(R) XC, which builds on the success of Biovail's TIAZAC(R), Canada's leading once-daily diltiazem formulation, will be launched in Canada in the first quarter of 2005.

TIAZAC(R) XC, if approved for the treatment of angina, will represent a further advance in the management of this condition. TIAZAC(R) XC combines Biovail's advanced drug-delivery technology with the proven efficacy of diltiazem, a calcium channel blocker calcium channel blocker
n.
Any of a class of drugs that inhibit movement of calcium ions across a cell membrane, used in the treatment of cardiovascular disorders.
 (CCB CCB Calcium channel blocker, see there ) that has been trusted by Canadian physicians for more than 20 years.

"The dual indication of TIAZAC(R) XC in hypertension and chronic stable angina chronic stable angina Cardiology The most common form of angina, characterized by chest discomfort due to myocardial ischemia, and unaccompanied by myocardial necrosis; the cause of pain is uncertain, possibly substances released during transient ischemia–eg, , combined with its unique Diffusion Technology (DiTech(TM)) System, will make TIAZAC(R) XC an excellent choice for the physician in the management of two very important cardiovascular risk factors," says Suzanne Villeneuve, General Manager of Biovail Pharmaceuticals Canada, the Canadian sales and marketing division of Biovail Corporation in Mississauga, Ont.

Non-dihydropyridine calcium channel blockers Calcium Channel Blockers Definition

Calcium channel blockers are medicines that slow the movement of calcium into the cells of the heart and blood vessels.
 (NDHP NDHP North Dakota Highway Patrol  CCBs), like TIAZAC(R) XC, are often prescribed by physicians to treat angina because they improve cardiac blood flow and reduce heart rate. This combined effect balances the supply and demand of oxygen in the cardiac tissue, thereby reducing chest pain. TIAZAC(R) XC also lowers blood pressure which further reduces strain on the heart.

About Angina

Angina - chest pain or discomfort that occurs when the heart muscle does not get enough blood - affects nearly one million Canadians. Angina is a symptom of coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. , the most common kind of heart disease, and occurs when vessels that carry blood to the heart become narrowed and blocked due to atherosclerosis.

The choice of drug to control angina is usually dependent on the acuity and severity of the symptoms, as well as the presence of other existing conditions. NDHP CCBs, including TIAZAC(R) XC, are a family of medications used primarily to lower blood pressure (hypertension) and to treat chest pain caused by coronary artery disease (angina). They are also sometimes used to treat arrhythmias (irregular heart rhythms) or diabetic nephropathy. NDHP CCBs are generally well tolerated.

About TIAZAC(R) XC

TIAZAC(R) XC (diltiazem HCl) is currently indicated for the treatment of high blood pressure (hypertension). TIAZAC(R) XC is a brand name for once-daily, extended-release tablet formulation for bedtime administration in dosages of 120 mg-360 mg per day. TIAZAC(R) XC works by slowing the heart rate, and by relaxing and widening blood vessels (arteries), which reduces blood pressure. Widening of the coronary arteries also increases the amount of blood reaching the heart, which can reduce the symptoms of angina.

About Biovail Corporation

Biovail Corporation is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, sale and promotion of pharmaceutical products utilizing advanced drug-delivery technologies. For more information about Biovail, visit the company's Web site at www.biovail.com

For further information, please contact Ken Howling at 905-286-3000 or send inquiries to ir@biovail.com.

"Safe Harbor" Statement Under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995

To the extent any statements made in this release contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements on our current expectations and projections about future events. Our actual results could differ materially from those discussed in, or implied by, these forward-looking statements. Forward-looking statements are identified by words such as "believe", "anticipate", "expect", "intend", "plan", "will", "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Forward-looking statements include, but are not necessarily limited to, risks and uncertainties, including the difficulty of predicting U.S. Food and Drug Administration ("FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
") and Canadian Therapeutic Products Directorate ("TPD") approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials and finished products, third parties, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission ("SEC") and the Ontario Securities Commission The Ontario Securities Commission (OSC) is a regulatory agency which administers and enforces securities legislation in the Canadian province of Ontario. The OSC is an Ontario Crown corporation which reports to the Ontario legislature through the Minister of Finance.  ("OSC O.S.C. n. short for Order to Show Cause. (See: Order to Show Cause) ").
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No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Oct 25, 2004
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