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Teva Announces Tentative Approval of Generic Maxalt(R) Tablets |
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17 Apr 2008 |
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Teva Pharmaceutical Industries announced today that the FDA has granted tentative approval for the Company’s ANDA to market its generic version of Merck’s migraine pain treatment Maxalt
JERUSALEM, Israel | April 17, 2008 | Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA - News) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company’s Abbreviated New Drug Application (ANDA) to market its generic version of Merck’s migraine pain treatment Maxalt(R) (Rizatriptan Benzoate) Tablets, equivalent to 5 mg and 10 mg base. Final approval of this product is anticipated upon expiration of patent protection for the brand product in June 2012.
The brand product had annual sales of approximately $193 million in the United States for the twelve months that ended December 30, 2007, based on IMS sales data.
About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva’s sales are in North America and Europe.
SOURCE: Teva Pharmaceutical Industries Ltd. |