FDA Approves Removal of "Not for Home Use" Label Restriction for Pliaglis

Crescita Therapeutics announced the U.S. Food and Drug Administration (FDA) has approved the Prior Approval Supplement (PAS) for Pliaglis following its mandated six-month review process, in line with the target action date under the Prescription Drug User Fee Act (PDUFA).

In 2017, Taro Pharmaceuticals, Crescita’s licensee for Pliaglis in the U.S. market, completed the study to support the removal of the Pliaglis "Not for Home Use" label restriction and filed the FDA submission with the proposed label change on June 8, 2018. The removal of the "Not for Home Use" label restriction is accompanied by the addition of a new user instruction sheet and product applicator. The approval of this submission triggers a milestone of US$0.5 million for Crescita.

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"We are delighted with the approval of this label change by the FDA. It marks a significant milestone as it will expand the ability of patients to have access to the drug and will facilitate our partner's efforts to increase market acceptance of Pliaglis in the U.S." said Serge Verreault, President and Chief Executive Officer of Cresctia.

Pliaglis, a lidocaine and tetracaine (7%/7%) formulation, is a U.S. FDA approved topical local anesthetic cream that provides safe and effective local dermal anesthesia on intact skin prior to superficial dermatological procedures, such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing and laser-assisted tattoo removal. This product contains lidocaine and tetracaine and utilizes the proprietary phase-changing topical cream "Peel" technology. The "Peel" technology consists of a drug containing cream which, once applied to a patient's skin, dries to form a pliable layer that releases drug into the skin. Following the application period, Pliaglis forms a pliable layer that is removed from the skin allowing the dermatological procedure to be performed with minimal to no pain.

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