Perrigo announced that the Food and Drug Administration (FDA) has approved Abbreviated New Drug Applications (ANDAs) for Nicotine Polacrilex Gum, the generic versions of GlaxoSmithKline’s Nicorette White Ice Mint Gum.
Nicorette Gum is indicated to help patients quit smoking by reducing nicotine withdrawal symptoms. Nicotine acts as an agonist at the nicotinic cholinergic receptors at the autonomic ganglia, in the adrenal medulla, at neuromuscular junctions, and in the brain. Its positive reinforcing properties are believed to be the result of the release of neurotransmitters including acetylcholine, beta-endorphin, dopamine, norepinephrine, serotonin, and others that mediate pleasure, arousal, elevated mood, appetite, and other desirable psychological states.
Perrigo’s Nicotine Polacrilex Gum will be available in 2mg and 4mg strengths.