Amphastar Announces FDA Approval for Teriparatide Injection

Core Viewpoint - Amphastar Pharmaceuticals, Inc. has received FDA approval for its teriparatide injection, which is bioequivalent and therapeutically equivalent to Eli Lilly's FORTEO® [1] Company Summary - Amphastar Pharmaceuticals announced the approval of its Abbreviated New Drug Application (ANDA) for teriparatide injection, USP 560 mcg/2.24mL (250 mcg/mL) single-patient-use prefilled pen [1] - The FDA's determination confirms that Amphastar's teriparatide is equivalent to Eli Lilly's product, indicating a significant milestone for the company in the competitive pharmaceutical market [1] Industry Summary - The approval of teriparatide injection highlights the ongoing developments in the pharmaceutical industry, particularly in the area of biosimilars and generic drugs [1] - The bioequivalence to a well-established product like FORTEO® may enhance market competition and provide more options for patients [1]