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FDA Mandates Major Opioid Label Revisions to Highlight Long-Term Risks

Pharmacy Times

Labels now emphasize the risks of higher doses and caution against abrupt discontinuation in dependent patients to prevent withdrawal and other harms. Expanded warnings include interactions with CNS depressants and rare outcomes like esophageal dysfunction, aligning with CDC's 2022 opioid prescribing guidelines.

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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. In 2022, CMS reevaluated 505(b)(2) drugs in relation to section 1847A of the Social Security Act (SSA). This went into effect in January 2022.”

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Researchers Evaluate Infection Control Challenges During an RSV Outbreak in a Cognitively Impaired Population

Pharmacy Times

1 RSV Outbreak in Long-Term Care Facility Researchers assessed the RSV outbreak that occurred in a long-term care facility in 2022 to identify successful strategies that other facilities can apply in similar situations.

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Pharmacy Focus: Importance of Mental Health for Patients and Pharmacists Alike

Pharmacy Times

Hillary Blackburn Pharmacy Focus Episode 40: Holistic Wellness for Oncology Patients Pharmacy Focus Episode 41: Medication Adherence Best Practices Pharmacy Focus Episode 42: Current Mental Health Treatment Needs Pharmacy Focus Episode 43: Financial Wellness FAQ with Tim Ulbrich BONUS: APhA 2022 feat.

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Ropeginterferon Alfa 2b Is Well-Tolerated, Efficacious in Treatment of Prefibrotic Myelofibrosis

Pharmacy Times

2-5 In the multicenter, phase 2, open-label prospective study, researchers investigated ropeg-IFN-α2b treatment in patients with profibrotic MF or DIPSS low-intermediate-1 risk MF. Updated October 6, 2022. With phase 3 trial win, PharmaEssentia plots label expansion for rare blood cancer treatment Besremi. REFERENCES 1.

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ADA 2025: Advances in Type 2 Diabetes Management With Tirzepatide

Pharmacy Times

1 Image credit: Cynthia | stock.adobe.com The discussion featured Vivian Fonseca, MD, of the Tulane University School of Medicine, who presented an overview of tirzepatide based on the FDA-approved label and clinical guidelines. May 16, 2022. 1 “[Tirzepatide] has been a tool that has helped me get my blood glucose under control.

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Mitomycin Intravesical Solution Receives FDA Approval for Non-Muscle Invasive Bladder Cancer

Pharmacy Times

November 16, 2022. Primary chemoablation of recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer with UGN-102: A single-arm, open-label, phase 3 trial (ENVISION). Global research trends in non-muscle invasive bladder cancer: Bibliometric and visualized analysis. Front Oncol. doi:10.3389/fonc.2022.1044830