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FDA Alert

FDA Alert

AuroMedics Pharma LLC is voluntarily recalling one lot of Levofloxacin in 5% Dextrose Injection 250mg/50mL in a Single-Use flexible container NDC 55150-243-46, Lot CLF160003, Expiry date May 2018, to the hospital level.

The FDA has finalized a rule first proposed in 2015 that finds that triclosan and 23 other active ingredients are not generally recognized as safe and effective (GRASE) for use in over-the-counter (OTC) health care antiseptic products – including health care personnel hand washes and rubs, surgical hand scrubs and rubs, and patient antiseptic skin preparations — because no additional safety and effectiveness data were provided to the FDA to support monograph conditions for these 24 active ingredients.

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved ISENTRESS® (raltegravir), the company’s integrase inhibitor, for use in combination with other antiretroviral agents, for the treatment of HIV-1 in neonates – newborn patients from birth to four weeks of age – weighing at least 2 kg.

The FDA approved approved letermovir (Prevymis) to help prevent cytomegalovirus (CMV) infections and disease in adults previously exposed to the common virus who have received an allogeneic hematopoietic stem cell transplant (HSCT), otherwise known as a bone marrow transplant.  

SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) is voluntarily recalling various lots of injectable products to the hospital level. 

FDA approves first test for screening Zika virus in blood donations The U.S. Food and Drug Administration today approved the cobas Zika test, a qualitative nucleic acid test for the detection of Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components, and from living organ donors. 

The U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis.

The U.S. Food and Drug Administration today approved Baxdela (delafloxacin), a new antibacterial drug to treat acute bacterial skin and skin structure infections. Baxdela is available for intravenous and oral use.

FDA Alert

IDSA continues to recommend the use of neuraminidase inhibitor antiviral drugs in the treatment of influenza.