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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

It turns out that a side effect of some of the atypical antipsychotics is that they can cause or worsen RLS.[ref] This presents a picture of dopamine being important at the right level and at the right time of day

Baseline characteristics of study participants are presented in Table 1

For pre-mixed compounded vials: Long-term bulk storage is not practical because the BUD limits shelf life to 30 to 90 days

The data, from ten patients treated with GS-0976 20 mg taken orally once daily for 12 weeks, indicated that treatment was associated with statistically significant improvements in liver fat content and noninvasive markers of fibrosis (NCT02856555)