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Salvat Laboratories Submits NDA to FDA

Submits to the U.S. FDA the request for approval of Clobetasol, a new drug for the treatment of inflammation and pain after eye surgery.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Salvat, the international laboratory that has developed and owns Cristalmina, Gama Relive, Tebarat and Cetraxal products, has submitted the NDA documentation for a new drug application to the U.S. Food and Drug Administration (FDA) for approval of Clobetasol, the first ocular corticosteroid formulated in a nanoemulsion for inflammation and pain in patients undergoing eye surgery. The submission to the FDA follows the success of two phase III clinical trials conducted between 2020 and 2021. Cl...

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