Taro receives approval for Etodolac Extended-Release Tablets ANDA
Taro receives approval for Etodolac Extended-Release Tablets ANDA
HAWTHORNE, N.Y., March 13, 2003 -- Taro Pharmaceutical Industries reported that its U.S. affiliate has received approval from the FDA for its Abbreviated New Drug Application (ANDA) for Etodolac Extended-Release (XL) Tablets in three strengths, 400 mg, 500 mg and 600 mg.
Etodolac XL Tablets are AB-rated (bioequivalent) to Wyeth's Lodine XL Tablets in the same three strengths. Etodolac is a prescription product used in managing the signs and symptoms of both osteoarthritis and rheumatoid arthritis.
Taro currently manufactures and markets Etodolac Capsules in 200 mg and 300 mg strengths and Etodolac Tablets in 400 mg and 500 mg strengths. The Taro products are AB-rated to Lodine Capsules and Lodine Tablets in the same strengths.
"Etodolac XL joins our other etodolac products, extending our oral dose product line and giving physicians important options in matching an arthritis therapy to the precise needs of their patients," said Barrie Levitt, M.D., Chairman of the Company.
Source: Taro Pharmaceutical Industries Ltd. www.taro.com
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