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NEWS
Gelteq Receives FDA Approval of its Suitability Petition for New Animal Drug
Tuesday, 17th December at 8:30 am
NEW YORK, Dec. 17, 2024 (GLOBE NEWSWIRE) -- Gelteq Limited (NASDAQ: GELS) ("Gelteq" or the "Company"), a clinical and biotechnology company focused on developing and commercializing white label gel-based delivery solutions for prescription drugs, nutraceuticals, pet care, sports, and other products, announces today that the U.S. Food and Drug Administration ("FDA") has approved its suitability petition for a new animal drug under development. The new animal drug leverages Gelteq's ingestible gel platform designed for nutrient and drug delivery. A suitability petition is a request by a drug sponsor to submit an abbreviated new animal drug application ("ANADA") for a proposed innovative new animal drug that differs from a previously FDA approved generic animal drug.
"We believe there is enormous opportunity for us in the animal pharmaceuticals market, as there is a significant need to deliver medications more efficiently," Gelteq co-founder and CEO Nathan Givoni said. "This pathway, which is essentially a faster track as opposed to the standard new animal drug application (NADA) pathway, is a strategic way for us to expedite our entry into the animal drug space and provide long-term value for all our stakeholders."
Tuesday, 17th December at 8:30 am
NEW YORK, Dec. 17, 2024 (GLOBE NEWSWIRE) -- Gelteq Limited (NASDAQ: GELS) ("Gelteq" or the "Company"), a clinical and biotechnology company focused on developing and commercializing white label gel-based delivery solutions for prescription drugs, nutraceuticals, pet care, sports, and other products, announces today that the U.S. Food and Drug Administration ("FDA") has approved its suitability petition for a new animal drug under development. The new animal drug leverages Gelteq's ingestible gel platform designed for nutrient and drug delivery. A suitability petition is a request by a drug sponsor to submit an abbreviated new animal drug application ("ANADA") for a proposed innovative new animal drug that differs from a previously FDA approved generic animal drug.
"We believe there is enormous opportunity for us in the animal pharmaceuticals market, as there is a significant need to deliver medications more efficiently," Gelteq co-founder and CEO Nathan Givoni said. "This pathway, which is essentially a faster track as opposed to the standard new animal drug application (NADA) pathway, is a strategic way for us to expedite our entry into the animal drug space and provide long-term value for all our stakeholders."
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