News | February 7, 2001

Teva gains final approval for Nifedipine XL, Etodolac

Source: TEVA Pharmaceutical Ind.

Teva USA to launch both products immediately

BUSINESS WIRE — Teva Pharmaceutical Industries Ltd. (Jerusalem) 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Teva and its partner Biovail had requested that Mylan's 180-day exclusivity position on Nifedipine XL 30 mg tablets be rescinded subsequent to a Mylan agreement with Pfizer.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 United States 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.

For more information, contact Bill Fletcher, president and CEO of Teva North America, at 215-591-8800.