For a novel sterile injectable 505(b)(2) oncology supportive care product for US market
Zydus Lifesciences has entered into an exclusive licensing and commercialization agreement with RK Pharma Inc of the US for a novel sterile injectable 505(b)(2) oncology supportive care product for the US market.Under the terms of this agreement, RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA submission and commercialization of the product in the US.
The product, developed under the 505(b)(2) pathway, is expected to be filed in 2026 and will provide a formulation that is intended to provide reduced dosing error and enhanced compliance of healthcare professionals.
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