RECALL: American Regent Recalls Calcium Gluconate Injection 10%
American Regent is conducting a voluntary nationwide recall of one lot of calcium gluconate injection 10% because some of the vials may contain silicone particles.
Diagnosis & Disease Information
Phase 3 Study of dermaPACE for Diabetic Foot Ulcers
Sanuwave Health announced positive results from its Phase 3 study of dermaPACE for the treatment of diabetic foot ulcers.
laVív Approved for Nasolabial Fold Wrinkles
Fibrocell Science announced that the FDA has approved laVív (azficel-T) for the improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults.
NDA Accepted for Ivermectin for Head Lice
Topaz Pharmaceuticals announced the FDA has accepted for filing the NDA for ivermectin, a topical cream used to treat head lice in children and adults.
SAFETY ALERT: FDA Continues Review of Cancer Risk Associated with TNF blockers, Azathioprine, and/or Mercaptopurine
The FDA continues to receive reports of hepatosplenic T-Cell lymphoma (HSTCL) in adolescents and young adults treated for Crohn’s disease and ulcerative colitis with tumor necrosis factor (TNF) blockers, as well as azathioprine, and/or mercaptopurine.
SAFETY ALERT: Risk Evaluation and Mitigation Strategy (REMS) for Yervoy
Bristol-Myers Squibb informed healthcare professionals about the Risk Evaluation and Mitigation Strategy (REMS), developed in collaboration with the FDA, that is required to ensure that the benefits of Yervoy (ipilimumab) outweigh the risks of severe and fatal immune-mediated adverse reactions.
Yervoy Approved for Metastatic Melanoma
Bristol-Myers Squibb announced that Yervoy (ipilimumab injection) has been approved for the treatment of late stage (metastatic) melanoma.
Zyclara Approved for Treating External Genital Warts
Zyclara (imiquimod cream, Graceway Pharmaceuticals) has been approved for the treatment of external genital and perianal warts in patients ≥12 years of age.
H&P Industries Recalls Povidine Iodine Prep Pads
H&P Industries announced a voluntary recall of all lots of its povidine iodine prep pads, which are private labeled for many accounts.
Phase 2b Study of ATX-101 for Submental Fat Reduction
Kythera Biopharmaceuticals presented additional efficacy data from a Phase 2b study evaluating ATX-101 for the reduction of submental fat.
