Taro Pharmaceuticals Announces Tentative ANDA Approval
Enalapril Maleate and Hydrochlorothiazide Tablets USP Receive Tentative FDA Approval
HAWTHORNE, N.Y., Apr 20, 2001 (BUSINESS WIRE) -- Taro Pharmaceutical Industries Ltd. (Nasdaq: TARO chart, msgs) today reported that the Company received notification from the U.S. Food and Drug Administration (FDA) for the tentative approval of its Abbreviated New Drug Application (ANDA) for Enalapril Maleate and Hydrochlorothiazide Tablets USP, 5 mg/12.5 mg and 10 mg/25 mg (Enalapril/HCTZ).
Enalapril/HCTZ is a cardiovascular drug used in the treatment of hypertension, with a diuretic component. Enalapril/HCTZ is bioequivalent to Merck's Vaseretic(R) Tablets. The U.S. market for the product is estimated by industry sources to be $57 million.
The tentative approval comes nearly one year before the patent and pediatric exclusivity on Vaseretic(R) expire on March 18, 2002. Taro currently expects to begin selling the product in the U.S. market at that time.
Growing Cardiovascular Line
"Taro has a growing number of cardiovascular products in the U.S. market," stated Barrie Levitt, M.D., FACC, Chairman of the Company. "Taro is committed to cardiology, and we expect to continue building our cardiovascular product line." The Company currently markets Warfarin Sodium Tablets and Acetazolamide Tablets, in addition to the more recent approvals for Amiodarone Hydrochloride Tablets, Enalapril Maleate Tablets and Enalapril/HCTZ.
Since 1996, Taro has introduced an increasing number of oral dosage form products in the U.S. market. Today, Taro has ANDA approvals for 14 oral dosage form products in 33 varying strengths. Taro plans to continue expanding its oral dosage form offering in the U.S.
In January 2001, Taro received approval from the FDA on its ANDA for Enalapril Maleate Tablets in strengths of 2.5 mg, 5 mg, 10 mg and 20 mg, bioequivalent to Merck's Vasotec(R) Tablets. In March 2001, the Company received approval from the FDA on its ANDA for Amiodarone Hydrochloride Tablets 200 mg, bioequivalent to Wyeth-Ayerst Laboratories' Cordarone(R) Tablets.
Taro currently has 9 ANDAs submitted to the FDA (including the tentative approval for Enalapril Maleate/HCTZ), and multiple international filings with regulatory agencies around the world.
Taro is a multinational, science-based pharmaceutical company dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.
For further information on Taro Pharmaceutical Industries Ltd., visit the Company's website at www.taropharma.com.
To receive additional information on Taro Pharmaceutical Industries Ltd., at no charge, dial 1-800-PRO-INFO and enter company code 104 or ticker symbol TARO.
Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Although Taro Pharmaceutical Industries Ltd. believes the expectations reflected in such forward-looking statements to be based on reasonable assumptions, it can give no assurance that its expectations will be attained. Factors that could cause actual results to differ include industry and market conditions, slower than anticipated penetration of new markets, changes in the Company's financial position, regulatory actions, and other risks detailed from time to time in the Company's SEC reports, including its Annual Report on Form 20-F for the last fiscal year ended December 31, 1999.
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