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TEVA ANNOUNCES FINAL APPROVALS OF NIFEDIPINE XL 30MG AND ETODOLAC ER 400MG WILL LAUNCH IMMEDIATELY.


Business Editors

JERUSALEM, Israel--(BUSINESS WIRE)--February 7, 2001

Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in  Ltd. (Nasdaq: TEVA) announced today that the 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.
) has awarded final approval for Nifedipine nifedipine /ni·fed·i·pine/ (ni-fed´i-pen) a calcium channel blocking agent used as a coronary vasodilator in the treatment of coronary insufficiency and angina pectoris; also used in the treatment of hypertension.  XL 30 mg tablets and Etodolac etodolac /eto·do·lac/ (e-to-do´lak) a nonsteroidal antiinflammatory drug used as an analgesic and antiinflammatory, especially to treat arthritis.

e·to·do·lac
n.
 400 mg tablets and Teva USA will launch both products immediately.

Nifedipine XL is the generic version of Pfizer's drug Procardia XL(R) for the treatment of hypertension and angina. The approval of the 30mg strength was granted following a Citizen's Petition in which Teva and its partner Biovail had requested that Mylan's 180-day exclusivity position on Nifedipine XL 30 mg tablets be rescinded subsequent to a Mylan agreement with Pfizer. FDA agreed with Teva's position that the Mylan/Pfizer agreement rendered Mylan ineligible for exclusivity and that in any case Mylan's exclusivity would have expired as the marketing of the Pfizer-supplied product constituted "commercial marketing" and thus triggered any possible exclusivity period.

This product is included in the exclusive US marketing agreement between Teva and Biovail relating to relating to relate prepconcernant

relating to relate prepbezüglich +gen, mit Bezug auf +acc 
 Biovail's line of generic sustained release Sustained-release (SR), extended-release (ER, XR, or XL), time-release or timed-release, controlled-release (CR), or continuous-release (CR or Contin  products, and the ANDA ANDA
abbr.
abbreviated new drug application
 approval was issued to Biovail. Branded sales of this product strength in the U.S. were $ 130 million. Teva has already introduced the 60mg version of Nifedipine XL last October. In December Biovail announced that it had also filed the Nifedipine XL 90 mg and subsequent to receiving approval for this strength, Teva will have all three strengths.

Teva also announced final approval for Etodolac ER 400 mg tablets following the expiry of another company's exclusivity period and will launch the product immediately. Etodolac ER is the generic version of Wyeth-Ayerst's NSAID NSAID: see nonsteroidal anti-inflammatory drug.  Lodine XL(R). US brand sales of this strength were approximately $ 70 million. Teva has already introduced the 500 mg and 600 mg version of Etodolac ER last September with a 180-day exclusivity period. Teva is now the only company with generic approval for all three strengths of this product.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 50 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. Over 85% of Teva's sales are outside Israel, mainly in the North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere.  and Europe. The Company develops, manufactures and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients.

Safe Harbor Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
 Statement: 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.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Feb 7, 2001
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