Pharma major Dr. Reddy’s Laboratorieson Monday said the U.S. Food and Drug Administration (USFDA) has approved Xeglyze (abametapir) lotion, 0.74%, used to treat head lice infestation.
The company is working to commercialise the product through partners. The approval of the NDA ( new drug application) also triggers the contractual pre-commercialisation milestone of $20 million payable to Hatchtech Pty Ltd.,according to a release from Dr.Reddy’s said.
In September 2015, Dr.Reddy’s had announced a commercialisation deal with Australian firm Hatchtech for Xeglyze lotion. “The exclusive rights for this product (Xeglyze lotion) are applicable for the territories of the U.S., Canada, India, Russia and the CIS, Australia, New Zealand and Venezuela,” it had said.
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Under the deal terms, Dr. Reddy’s had agreed to pay Hatchtech $10 million upfront, upto $50 million based on pre- commercialisation milestones and an undisclosed amount based on post commercialisation milestones. The active drug substance for Xeglyze lotion was developed in collaboration with Dr. Reddy’s Custom Pharmaceutical Services (CPS) business unit.