Drug Development
Hi-Tech Pharmacal Receives Tentative Approval for Calcipotriene Topical Solution
Published in Medical Letter on the CDC and FDA, April 15th, 2007
Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced that the US Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for Calcipotriene topical solution, 0.005%. Hi-Tech's Calcipotriene topical solution is the generic equivalent of Warner Chilcott's Dovonex(R) topical solution, 0.005% indicated for the treatment of psoriasis of the scalp, which had sales of $13 million in 2006 based on IMS sales data. Hi-Tech does not plan to market its generic version of Dovonex(R) topical solution prior to expiration of patent 4,866,048, which is due to expire on December 29, 2007.
Hi-Tech is a specialty...
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