Gelteq Limited announced that the U.S. Food and Drug Administration (FDA) has approved its suitability petition for a new animal drug under development. This approval leverages Gelteq’s ingestible gel platform for nutrient and drug delivery.
The suitability petition pathway allows for an abbreviated new animal drug application (ANADA) for a proposed innovative new animal drug that differs from a previously FDA-approved generic animal drug. Gelteq proposed changing a reference drug from a pill form into an oral gel form.
The FDA found that the proposed changes did not require Gelteq to conduct further investigations into safety and effectiveness, which helps reduce the timeframe to potential approval. This strategic pathway is expected to expedite Gelteq's entry into the animal drug market.
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