Pfenex Gets US Teriparatide Nod

Partner Alvogen is expected to launch the Forteo rival upon an FDA equivalence decision

 
• By Dave Wallace

Pfenex’ PF708 version of Forteo, submitted under the US 505(b)(2) hybrid regulatory pathway, has been approved by the FDA. Marketing partner Alvogen is expected to launch as soon as the FDA decides on the product’s equivalence rating after Pfenex submits a key study.

FDA Approved
Pfenex’ teriparatide has been approved by the FDA • Source: Shutterstock

Pfenex has obtained US Food and Drug Administration approval for its PF708 hybrid 505(b)(2) rival to Eli Lilly’s Forteo (teriparatide) brand.

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