Hi-Tech Pharmacal (HITK) Receives Tentative FDA Approval for Ciclopirox Topical Solution
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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 Ciclopirox topical solution, 8%.
Hi-Tech's Ciclopirox topical solution is the generic equivalent of Dermik Laboratories' nail fungus treatment Penlac topical solution, 8%, which had sales of $87 million in 2006 based on IMS sales data. Final approval is expected upon expiration of the brand's patent on September 18, 2007.
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