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Natco Pharma Submits ANDA to FDA for Generic Breast Cancer Drug

by Kathy Jones on  June 24, 2011 at 6:31 PM Drug News   - G J E 4
Natco Pharma announced that it has submitted an abbreviated new drug application (ANDA) to the US Food and Drug Administration for the sale of its generic breast cancer drug, Lapatinib Ditosylate tablets which is will be manufacturing in partnership with Lupin Ltd.
 Natco Pharma Submits ANDA to FDA for Generic Breast Cancer Drug
Natco Pharma Submits ANDA to FDA for Generic Breast Cancer Drug
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Announcing the partnership in a press statement, Lupin said that the Lapatinib Ditosylate tablets, which are sold under the brand name of Tykerb in the US, had annual sales of over $113 million last year.

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"Tykerb had sales of $113.6 million as of March, 2011, according to IMS health. Natco and Lupin believe that they are the first to file an ANDA containing a paragraph IV certification for Lapatinib", the company said.

Source: Medindia
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