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Key Highlights: 48 PSGs for products with no approved ANDAs (25 complex products) 39 PSGs for complex products (6 new, 33 revised) Therapies for COPD, opioid overdose, type 2 diabetes, major depressive disorder, and more Notable PSGs: Ensifentrine inhalation suspension (COPD, RLD: OHTUVAYRE) Naloxone hydrochloride nasal spray (Opioid overdose, RLD: REZENOPY) Semaglutide oral tablet (Type 2 diabetes, RLD: RYBELSUS) Trazodone hydrochloride ER oral tablet (MDD, RLD: OLEPTRO) Link : By publishing PSGs, FDA continues to promote innovation in generic development while advancing public health and patient access to cost-effective medicines

The relative lack of progress in the management of gastroparesis associated with gastrointestinal symptoms reflects, in part, the pursuit of overly simplistic concepts and the fundamental importance of defining pathophysiology for the rational development of novel and effective therapy

Nikan, M

The New York Times

This mechanism differs fundamentally from traditional smoking-cessation medications like varenicline or bupropion, which work through different neurochemical pathways