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Zubsolv News
Buprenorphine + Naloxone Safe for Opioid Addiction in Pregnancy
MONDAY, Aug. 12, 2024 – Pregnancies exposed to buprenorphine combined with naloxone have similar or more favorable neonatal and maternal outcomes as those exposed to buprenorphine alone, according...
FDA Medwatch Alert: FDA Warns About Dental Problems with Buprenorphine Medicines Dissolved in the Mouth to Treat Opioid Use Disorder and Pain
What safety concern is FDA announcing? The U.S. Food and Drug Administration (FDA) is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the...
FDA Medwatch Alert: Opioid Pain Relievers or Medicines to Treat Opioid Use Disorder - FDA Recommends Health Care Professionals Discuss Naloxone with All Patients when Prescribing
ISSUE: FDA is requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder (OUD) to add new recommendations about naloxone to the prescribing information....
FDA Approves Unique Low Dosage of Zubsolv
Uppsala, Sweden – October 6, 2016 – Orexo AB (publ.) announced today that it has received approval from the US Food and Drug Administration (FDA) of a new unique low dose, 0.7mg/0.18 mg, tablet of Zub...
FDA Medwatch Alert: Opioid Pain or Cough Medicines Combined With Benzodiazepines: Drug Safety Communication - FDA Requiring New Boxed Warnings About Serious Risks and Death
ISSUE: FDA review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects,...
FDA Medwatch Alert: Opioid Pain Medicines: Drug Safety Communication - New Safety Warnings Added to Prescription Opioid Medications
ISSUE: FDA is warning about several safety issues with the entire class of opioid pain medicines. See the FDA Drug Safety Communication for a complete listing. These safety risks are potentially h...
FDA Approves Zubsolv for Induction of Buprenorphine Maintenance Therapy in Patients Suffering from Opioid Dependence
Uppsala, Sweden – August 11, 2015 - Orexo AB (publ) announced today that the U.S. Food and Drug Administration (FDA) has approved Zubsolv (buprenorphine/naloxone CIII sublingual tablet) for induction ...
FDA Approves Two Higher Dosage Strengths of Zubsolv
Uppsala, Sweden – December 12, 2014 – Orexo AB announces today that it has received approval from the U.S. Food and Drug Administration (FDA) of two higher dosage strengths of Zubsolv (bu...