Novavax withdraws Estrasorb NDA after FDA info request
COLUMBIA, Tenn., April 24 (Reuters) - Women's health care company Novavax Inc. (NasdaqNM:NVAX - news) on Wednesday said it was withdrawing its new drug application for Estrasorb after the U.S. Food and Drug Administration had asked for more information on the topical cream product.
The FDA, after completing its review of the product, had asked for more information related to the Chemistry Manufacturing and Controls section of the filing, Novavax said.
The agency did not bring up any questions on the safety or effectiveness of Estrasorb. But the company said it would now voluntarily withdraw its new drug application for the topical estrogen replacement therapy and resubmit it once it has prepared its responses.
The decision is also a setback for King Pharmaceuticals Inc. (NYSE:KG - news), which has the worldwide license to market, distribute and sell Estrasorb after it is approved, except in the U.S and Puerto Rico, where King and Novavax will co-market the product.
Insider Buy
2002-03-21 O'DONNELL, DENIS M.
Chairman 166,667 Option Exercise at $6.19 per share.
(Cost of $1,031,668)
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