FDA Approves First-in-Class Treatment for IBS-C
Ibsrela is a sodium/hydrogen exchanger 3 (NHE3) inhibitor.
FDA
The FDA Seeks Your Feedback on New Measure for Fixed-Quantity Blister Packaging for Opioids
The US Food and Drug Administration is seeking feedback from healthcare professionals on its proposal to offer fixed-quantity blister packaging for a select number of opioid medications.
FDA Launches “Remove the Risk” Campaign for Safe Disposal of Unused Opioids
The U.S. Food and Drug Administration is launching on April 25, 2019, its “Remove the Risk” campaign, aimed at promoting the safe disposal of unused opioids.
New Tool Helps Alert the Public to Unlawfully Marketed Dietary Supplement Ingredients
In an effort to better alert the public of unlawful ingredients in dietary supplements, the FDA has created the Dietary Supplement Ingredient Advisory List, a new reference tool for consumers and manufacturers.
FDA Issues Final Rule on OTC Hand Sanitizers
The final rule states that certain active ingredients are not allowed to be used in OTC hand sanitizers, which are meant for use without water and soap.
FDA: Opioid Medication Labels Will Include More Information on Appropriate Tapering in Physically Dependent Patients
The Food and Drug Administration is requiring labeling changes for all opioid analgesics used in the outpatient setting, to provide additional guidance on safe opioid tapering. The changes will provide more information on how to safely decrease the dose in opioid-dependent patients. However, as the agency noted in a press release, “there is no standard…
FDA: Warning Letters Sent to Several Homeopathic Product Manufacturers Due to Quality Issues
The Food and Drug Administration (FDA) has issued warning letters to four homeopathic drug manufacturers due to serious concerns over the quality of the products produced by these companies.
Risks Associated With Transmucosal IR Fentanyls: Assessing the FDA Mitigation Strategy
Pharmacists, prescribers, and patients tend to have adequate knowledge of transmucosal immediate-release fentanyls for use in breakthrough cancer pain.
Second Complete Response Letter Issued for IV Meloxicam
The Food and Drug Administration (FDA) has sent a second Complete Response Letter to Recro Pharma concerning their New Drug Application for intravenous meloxicam.
FDA Warns Company Selling Misbranded Drugs With False Claims
The Food and Drug Administration (FDA) issued a warning letter to NutraPharma, for selling false and misleading products that claim to treat addiction and chronic pain. The products are sold via the website nyloxin.com.
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