Manufacturers can now adequately supply the market with varenicline at or below the acceptable intake limit of 37ng per day.
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Par’s generic version of Chantix is currently the only available one in the US.
The recalled lots of Chantix were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from May 2019 to September 2021.
To date, the Company has not received any reports of adverse events related to this recall.
Long-term use of a product containing N-nitroso-varenicline may be associated with an increased cancer risk based on data from closely related nitrosamine compounds.
The outpatient procedure provides noninvasive magnetic stimulation to areas of the brain known to be associated with addiction.
The FDA has granted Breakthrough Therapy designation to AXS-05 (Axsome Therapeutics) for the treatment of Alzheimer disease (AD) agitation.
The Nonprescription Drugs Advisory Committee (NDAC) of the Food and Drug Administration (FDA) has recommended the approval of the New Drug Application (NDA) from GlaxoSmithKline for an over-the-counter (OTC) nicotine mouth spray to aid in smoking cessation (9 to 6 vote). The nicotine mouth spray (NMS) delivers 1mg nicotine per spray; each dispenser would deliver…