fda-approval-letter
PHARMACY

Pliaglis’ ‘Not for Home Use’ label restriction gets green lighted

BY Sandra Levy

Crescita Therapeutics has received the green light from the Food and Drug Administration for removal of the “Not for Home Use” label restriction for Pliaglis.

“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.,” Cresctia president and CEO, Serge Verreault said.

Pliaglis, a lidocaine and tetracaine (7%/7%) formulation, is a 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, according to the company.

Taro launched the product in the United States in the first quarter of 2018.

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