Apotex, together with development and manufacturing partners Orbicular Pharmaceutical Technologies Pvt. Ltd. and Gland Pharma Limited, announced FDA approval of its Abbreviated New Drug Application for generic Infuvite Pediatric Injection. The product is eligible for 180‑day Competitive Generic Therapy (CGT) exclusivity for the single‑dose vial presentation, and Apotex will serve as the ANDA sponsor and lead commercialization efforts in the United States.
The pediatric approval follows the company’s April 13 FDA approval of its generic Infuvite Adult Injection, representing a second authorization within days for this multivitamin injectable product family. According to Apotex, the two approvals collectively expand parenteral nutrition options for both adult and pediatric patients.
Apotex stated that the Infuvite Pediatric program was supported by the combined scientific, regulatory, and manufacturing capabilities of Apotex, Orbicular, and Gland Pharma. The development effort included complex formulation work, analytical characterization, and preparation for sterile injectable manufacturing to support the FDA submission.
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