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Pain News (Page 5)
FDA Medwatch Alert: Biota Biosciences Issues Voluntary Nationwide Recall of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables Because They Were Marketed Without FDA Approval
May 20, 2020 – Biota Biosciences is voluntarily recalling the following lots in the table below of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables to the customer...
FDA Approves Anjeso (meloxicam injection) for the Management of Moderate to Severe Pain
MALVERN, Pa., Feb. 20, 2020 (GLOBE NEWSWIRE) – Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that the U.S. Food and Drug...
KemPharm Announces FDA Approval of sNDA for Two Additional Strengths of Apadaz (4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP)
CORALVILLE, Iowa, Jan. 07, 2019 (GLOBE NEWSWIRE) – KemPharm, Inc. (NASDAQ:KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, announced today...
FDA Medwatch Alert: Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration
ISSUE: The FDA is aware that patients undergoing treatment or management of pain are commonly given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use...
FDA Approves Dsuvia (sufentanil) Sublingual Tablets for Severe Pain
REDWOOD CITY, Calif., Nov. 2, 2018 /PRNewswire/ – AcelRx Pharmaceuticals, Inc. (AcelRx) (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of...
Pacira Announces FDA Approval of Exparel as a Nerve Block to Produce Regional Analgesia
PARSIPPANY, N.J., April 06, 2018 (GLOBE NEWSWIRE) – Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug...
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...
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