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Crescita Gets FDA Approval for Enhanced Formulation of Pliaglis
Nov. 06, 2019 09:13AM PST
Pharmaceutical InvestingThe company received approval from the US Food and Drug Administration for the enhanced formulation of its topical treatment Pliaglis.
Crescita Therapeutics (TSX:CTX) has announced that the US Food and Drug Administration (FDA) has approved the company’s enhanced formulation of Pliaglis.
As quoted in the press release:
While the U.S. patent covering the original formulation of Pliaglis® expired on September 28. 2019, the U.S. patent covering the Enhanced Formulation with extended protection to 2031, is in the process of being added to the Orange Book.
On May 2, 2019, our licensing partner for the U.S. market, Taro Pharmaceuticals Inc. (“Taro”) filed a CBE-30 supplement seeking approval for an enhanced formulation of Pliaglis which has improved application and removal properties as well as extended patent protection until 2031 in the U.S. and several other jurisdictions. The approval of the Enhanced Formulation triggers a US$0.75 million milestone under the terms of the out-licensing agreement in place with Taro.
“We are delighted with the FDA’s approval of the Enhanced Formulation of Pliaglis,” said Serge Verreault, President and CEO of Crescita. “With an improved formulation and extended patent protection, we are very optimistic about extending the commercial life of Pliaglis for many years to come.”