U.S. FDA Approves Removal of "Not for Home Use" Label Restriction for Pliaglis®
LAVAL, QC, Dec. 17, 2018 /PRNewswire/ - Crescita Therapeutics Inc. (TSX: CTX) (Crescita or the Company), a Canadian commercial dermatology company with a portfolio of non-prescription skincare products and prescription drug products for the treatment and care of skin conditions, diseases and their symptoms, is pleased to announce that 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 Inc. (Taro), our 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.
"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.
About Taro Pharmaceutical Industries Ltd.
Taro (NYSE: TARO) is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products. For further information on Taro, please visit the Company's website at www.taro.com.
Out-licensing Agreement with Taro Pharmaceuticals Inc.
On April 25, 2017, the Company entered into a Development and Commercialization License Agreement ("the Agreement") with Taro Pharmaceuticals Inc. Under the terms of the Agreement, Crescita granted Taro an exclusive license to sell and distribute Pliaglis and Flexicaine in the U.S. market. Crescita retained all rights to Pliaglis in Canada and Mexico and continues to explore alternatives for the preferred commercial distribution pathway for Pliaglis in these territories. During the first quarter of 2018, the Company announced that the product was launched in the U.S. by Taro.
About Crescita Therapeutics Inc.
Crescita (TSX: CTX) is a publicly traded, Canadian commercial dermatology company with a portfolio of non-prescription skincare products and prescription drug products for the treatment and care of skin conditions and diseases and their symptoms. Crescita owns multiple proprietary drug delivery platforms that support the development of patented formulations that can facilitate the delivery of active drugs into or through the skin. For additional information, please visit www.crescitatherapeutics.com.
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