YARAL Pharma Now the Exclusive Supplier of Authorized Generic Levothyroxine Sodium Capsules in the U.S. Market
IBSA USA Renews Partnership With Professional Golfer Aza Muñoz to Promote Tirosint®-SOL
Xeris Biopharma Holdings, Inc., a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing innovative products across a range of therapies, announced topline results from its recently completed phase 2 multi-centre, open label, study of XP-8121 for the treatment of adults with hypothyroidism. XP-8121 employs the company’s XeriSol formulation technology to enable a novel once-weekly SC injection of levothyroxine. This novel formulation significantly increases the bioavailability of levothyroxine reducing overall drug exposure and enabling a dosing regimen with the potential to mitigate the many challenges associated with achieving and maintaining a normal level of thyroid stimulating hormone (TSH) with daily oral formulations of levothyroxine.
Xeris Biopharma Announces Positive Topline Phase 2 Clinical Data of Its Investigational XeriSol™-Formulated Once-Weekly Subcutaneous (SC) Levothyroxine (XP-8121)
PARSIPPANY, N.J.--(BUSINESS WIRE)--The U.S. Food and Drug Administration (FDA) has approved two new changes to the label of Tirosint-SOL (levothyroxine sodium) oral solution, a unique formulation of levothyroxine (LT4) for the treatment of hypothyroidism. The first regards the use of Tirosint-SOL in the presence of proton pump inhibitor (PPI) therapy. The second regards the timing of Tirosint-SOL administration. Both label changes help to differentiate Tirosint-SOL from other levothyroxine therapies.
Enforcement Report - Week of November 15, 2023
Zydus Lifesciences gets USFDA nod to market generic drug
Enforcement Report - Week of March 8, 2023
Enforcement Report - Week of March 1, 2023
FDA Confirms Paragraph IV Patent Litigation for Levothyroxine Sodium Oral Solution