The August update to the AHFS Drug Information/Essentials database has been published. Highlights from this month’s update include:
New Full-Length Monographs
- None
New First-Release Monographs
- Trientine (Syprine®) – 64:00 (Heavy Metal Antagonists)
- Indicated in the treatment of patients with Wilson’s disease who are intolerant of penicillamine
- Delafloxacin (Baxdela®) – 8:12.18 (Quinolones)
- Indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria
- Betrixaban (Bevyxxa®) – 20:12.04.14 (Direct Factor Xa Inhibitors)
- Indicated for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE
- Naltrexone And Bupropion (Contrave®) – 28:20.08.92 (Anorexigenic Agents, Miscellaneous)
- Indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia)
- Guselkumab (Tremfya®) – 84:92 (Skin and Mucous Membrane Agents, Miscellaneous)
- Indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy
- L-Glutamine (Endari®) – 92:92 (Other Miscellaneous Therapeutic Agents)
- Indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older
FDA MedWatch Alerts
- None