More MS news articles for Oct 2001

FDA Issues Approvable Letter on Prefilled Syringe for COPAXONE(R)

October 2, 2001  7:00am
Source: PR Newswire

KANSAS CITY, Mo., Oct 2, 2001 /PRNewswire via COMTEX/ -- The Food and Drug Administration today granted an approvable letter to Teva Pharmaceuticals USA for COPAXONE(R) (glatiramer acetate injection) to be available in prefilled syringes. COPAXONE(R) is positioned to become the first and only relapsing-remitting multiple sclerosis drug therapy to offer its medication in a prefilled syringe approved in the United States. Current injectable MS therapies require mixing and preparation time.

The letter is one of the final steps in the approval process. Teva is working closely with the FDA to answer the remaining questions, and the company anticipates that the prefilled glass syringes will become available in early 2002. The prefilled syringe is expected to replace the previous mixable form of COPAXONE(R).

"Teva Neuroscience is dedicated to continuous improvements in the way COPAXONE(R) is delivered. A prefilled syringe should make traveling, working and maintaining an active lifestyle more convenient for people living with MS," said Larry Downey, President and CEO of Teva Neuroscience.

COPAXONE(R) is indicated for the reduction of relapses in relapsing- remitting multiple sclerosis. The most common side effects of COPAXONE(R) are redness, pain, swelling, itching, or a lump at the site of injection, flushing, chest pain, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness. These reactions are usually mild and seldom require professional treatment. Patients should tell their doctor about any side effects.

Some patients report a short-term reaction right after injecting COPAXONE(R) (glatiramer acetate injection). This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an injection, last about 15 minutes, and go away by themselves without further problems.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA), headquartered in Israel, is among the top 40 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. Teva Pharmaceuticals USA is a subsidiary of Teva Pharmaceuticals Industries Ltd. Over 80% of Teva's sales are in North America and Europe. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients.

This report contains forward-looking statements, which express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include the impact of pharmaceutical industry regulation, the difficulty of predicting FDA and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, acceptance and demand for new pharmaceutical products and new therapies, the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, uncertainties regarding market acceptance of innovative products newly launched, currently being sold or in development, the impact of restructuring of clients, reliance on strategic alliances, fluctuations in currency, exchange and interest rates, operating results, the impact of the year 2000 issue and other factors that are discussed in the Company's Annual Report on Form 20-F and the Company's other filings with the U.S. Securities and Exchange Commission.

Teva Neuroscience, Inc. is a subsidiary of Teva Pharmaceutical Industries Ltd.

Call 1-800-887-8100 or log onto WWW.COPAXONE.COM for more information about COPAXONE(R) (glatiramer acetate injection) or multiple sclerosis. Teva Neuroscience, Inc. markets COPAXONE(R).

COPAXONE(R) is a registered trademark of Teva Pharmaceutical Industries Ltd.

CONTACT: Aharon Schwartz of Teva Pharmaceutical Industries Ltd., +1-011-972-392-67277, , Holly Gibson of Fleishman- Hillard, Inc., 816-512-2349, , or Larry Downey of Teva Neuroscience, Inc., 816-508-5051,

For more information, please go to

SOURCE Teva Pharmaceuticals Industries Ltd.

CONTACT:    Aharon Schwartz of Teva Pharmaceutical Industries Ltd.,
                  +1-011-972-392-67277, , Holly Gibson of Fleishman-
                  Hillard, Inc., +1-816-512-2349, , or Larry Downey of
                  Teva Neuroscience, Inc., +1-816-508-5051,


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