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Monday 05 September 2005
Teva Announces Approval of Cefaclor ER Tablets
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has approved the Company’s ANDA for Cefaclor Extended Release Tablets USP, 375 mg and 500 mg.
This is the first generic approval for the 375 mg strength. Shipment of this product is expected to begin immediately.
Cefaclor Extended Release Tablets are the AB-rated generic equivalent of Eli Lilly’s Ceclor CD, marketed by Elan Corporation. Cefaclor Extended Release Tablets are a cephalosporin antibiotic with annual sales of $14 million.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 35 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. Over 80% of Teva’s sales are in North America and Europe. The company develops, manufactures and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients.