Apotex announces FDA approval of generic Infuvite Pediatric Injection

Apotex said the U.S. Food and Drug Administration has approved its generic Infuvite Pediatric Injection.

The company announced the approval on April 27, saying the product is an ANDA for a single-dose vial and is eligible for 180-day Competitive Generic Therapy exclusivity.

Apotex said the pediatric approval comes shortly after its recent FDA approval for generic Infuvite Adult Injection. The company said the new product is being developed in partnership with Orbicular Pharmaceutical Technologies and Gland Pharma.

The announcement adds another injectable nutrition product to Apotex's portfolio and extends a run of recent regulatory wins for the company. For now, the key public details are limited to the company announcement, with no separate FDA posting cited in the release.

Apotex did not provide further commercial timing in the announcement. Any broader market impact will depend on when the product is launched and whether additional regulatory details are published.