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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
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The mechanism is by augmenting GI hormone release to empty food from the stomach in small increments to avoid spikes in blood sugar
Specialists recommend gently stepping the dose up, consuming lighter meals in smaller portions, and avoiding foods that are difficult to digest to help control skin and body side effects
You still control what you eat and whether you train
