View printer-friendly version
« Back
February 07, 2001 11:25 a.m.
Teva Announces Final Approvals of Nifedipine XL 30mg and Etodolac ER 400mg


Jerusalem, Israel, February 7, 2001 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has awarded final approval for Nifedipine XL 30 mg tablets and Etodolac 400 mg tablets and Teva USA will launch both products immediately.

Nifedipine XL is the generic version of Pfizer's drug Procardia XL® 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Teva and its partner Biovail had requested that Mylan's 180-day exclusivity position on Nifedipine XL 30 mg tablets be rescinded subsequent to a Mylan agreement with Pfizer.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 Biovail's line of generic sustained release products, and the ANDA 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 Lodine XL®. 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 and Europe. The Company develops, manufactures and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients.

Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current 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 Teva'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 Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competitive generic products, the impact of competition from brand-name companies that sell their own generic products or successfully extend the exclusivity period of their branded products, Teva's ability to rapidly integrate the operations of acquired businesses, the availability of product liability coverage in the current insurance market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration ("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, 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, exposure to product liability claims, dependence on patent and other protections for innovative products, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission ("SEC"). Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.