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TARGET-NASH Investigators

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

10.1007/s10068-017-0165-4 96