US sales of Vasostrict totaled USD890 m for the LTM ended September 30, 2021.
On December 15, 2021, the US Food and Drug Administration approved Eagle's abbreviated new drug application for vasopressin, a product that is indicated for use to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines.
Eagle was first-to-file an ANDA referencing Par Pharmaceutical, Inc.'s Vasostrict for the 20 units per ml presentation.
On August 31, 2021, the US District Court for the District of Delaware held that Eagle's proposed vasopressin product does not infringe any of the patents Par asserted against Eagle.
Par's appeal of the District Court's ruling remains pending, and Eagle will continue to vigorously defend against such appeal.
Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise.
Eagle's commercialized products include Ryanodex, Bendeka, Belrapzo, and its oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states.
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Precision Epigenomics partners with TruDiagnostic
Illumina's GRAIL divestment plan receives EC approval
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Ondine Biomedical's Steriwave approved for use by HCA UK
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial
Syros receives Fast Track Designation from FDA for tamibarotene in AML