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Pain News (Page 5)
FDA Approves Apadaz (benzhydrocodone and acetaminophen) for the Short-Term Management of Acute Pain
CORALVILLE, Iowa, Feb. 23, 2018 (GLOBE NEWSWIRE) – KemPharm, Inc. (NASDAQ:KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, announced today...
Inspirion Delivery Sciences Receives FDA Approval for RoxyBond (oxycodone hydrochloride) Immediate Release Tablets with Abuse-Deterrent Label Claims
BASKING RIDGE, N.J., April 26, 2017 /PRNewswire/ – Inspirion Delivery Sciences, LLC ("Inspirion") announced that the United States Food and Drug Administration (FDA) has approved RoxyBond™ (...
FDA Medwatch Alert: Codeine and Tramadol Medicines: Drug Safety Communication - Restricting Use in Children, Recommending Against Use in Breastfeeding Women
ISSUE: FDA is restricting the use of codeine and tramadol medicines in children. These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater...
Teva Receives FDA Approval for Vantrela ER (hydrocodone bitartrate) Extended-Release Tablets Formulated with Proprietary Abuse Deterrence Technology
JERUSALEM--(BUSINESS WIRE)--Jan. 18, 2017-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the U.S. Food and Drug Administration (FDA) approved Vantrela ER (hydrocodone...
FDA Approves Arymo ER (morphine sulfate) Abuse-Deterrent Formulation for the Treatment of Chronic Pain
WAYNE, Penn., Jan. 9, 2017 /PRNewswire/ – Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing...
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,...
Collegium Receives FDA Approval for Xtampza ER, an Analgesic with Abuse-Deterrent Properties
CANTON, Mass., April 26, 2016 (GLOBE NEWSWIRE) – Collegium Pharmaceutical, Inc. (Nasdaq:COLL) today announced that the U.S. Food and Drug Administration (FDA) approved Xtampza ER (oxycodone)...
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 Medwatch Alert: Morphine Sulfate 0.5 mg/mL Preservative Free in 0.9 percent Sodium Chloride by by Pharmakon Pharmaceuticals: Recall - Super-potent Product
ISSUE: FDA is alerting health care professionals of a voluntary recall of morphine sulfate 0.5 mg/mL preservative free in 0.9% sodium chloride, 1 mL syringe, CII, for intravenous use made and...
FDA Approves Belbuca (buprenorphine) Buccal Film for Chronic Pain Management
DUBLIN and RALEIGH, N.C., October 26, 2015 – Endo Pharmaceuticals Inc., a subsidiary of Endo International plc (NASDAQ: ENDP) (TSX: ENL), and BioDelivery Sciences International, Inc. (NASDAQ: BDSI),...
FDA Approves MorphaBond (morphine sulfate) Extended-Release Tablets with Abuse-Deterrent Properties
VALLEY COTTAGE, N.Y., Oct. 5, 2015 /PRNewswire/ – Inspirion Delivery Technologies LLC (“Inspirion”) announced that the United States Food and Drug Administration (FDA) has approved MorphaBond™ (morphi...
FDA Medwatch Alert: Tramadol: Drug Safety Communication - FDA Evaluating Risks of Using in Children Aged 17 and Younger
ISSUE: FDA is investigating the use of the pain medicine tramadol in children aged 17 years and younger, because of the rare but serious risk of slowed or difficult breathing. This risk may be ...
FDA Approves Oxycontin (oxycodone) for Children as Young as 11
FRIDAY, Aug. 14, 2015 – Limited use of the widely abused painkiller OxyContin in children as young as 11 years old was approved by the U.S. Food and Drug Administration. Studies by OxyContin maker...
Zogenix Receives FDA Approval for New Abuse-Deterrent Formulation of Zohydro ER
SAN DIEGO, Jan. 30, 2015 – Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of central nervous system (CNS) disorders, today announced...
FDA Medwatch Alert: Prescription and Over-the-Counter (OTC) Pain Medicines: Drug Safety Communication - FDA Review of Possible Risks of Pain Medicine Use During Pregnancy
[Posted 01/09/2015] ISSUE: FDA is aware of and understands the concerns arising from recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used ...
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