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Five Interesting Things To Know About Sulopenem (Orlynvah)

ID Stewardship

In this article an infectious diseases pharmacist discusses five interesting things to know about sulopenem (Orlynvah). In this article I will go intofive interesting things about solupenem. In case you are wondering, the FDA label does not list any hepatic dose adjustments. 2023 Jan 6;76(1):78-88. 2023 Jan 6;76(1):66-77.

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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. SHOW MORE The FDA intends to update opioid labels to highlight risks of addiction, overdose, and interactions, enhancing safety in pain management practices.

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New Frontline BTK Inhibitor Strategy Gains FDA Approval in Untreated Mantle Cell Lymphoma

Pharmacy Times

Although no formal contraindications are listed in AstraZeneca’s US labeling, perioperative management may require holding acalabrutinib 3 to 7 days before and after surgery to minimize bleeding risk. Hepatotoxicity and drug-induced liver injury are additional risks that require monitoring. Cancer Therapy Advisor. June 21, 2024.

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Zongertinib Approved by FDA for Patients With Nonsquamous NSCLC With HER2 TKD Mutations

Pharmacy Times

Beamion LUNG-1 is an open-label, phase 1 dose escalation trial evaluating zongertinib as a monotherapy in patients with advanced or metastatic small tumors; in this case, those with unresectable or metastatic, nonsquamous NSCLC with HER2 TKD mutations.

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Nemolizumab Shows Rapid, Sustained Efficacy in Atopic Dermatitis

Pharmacy Times

The findings emphasize nemolizumab’s swift response in treating atopic dermatitis symptoms, along with its long-term effectiveness in prurigo nodularis, as demonstrated in the OLYMPIA open-label extension trial (NCT04204616).

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FDA Removes REMS for Currently Approved BCMA-, CD19-Directed CAR T Cell Immunotherapies

Pharmacy Times

Accurate product labeling and ongoing safety monitoring remain essential for patient safety in CAR T therapies. Still, providing accurate product labeling for these products—which properly conveys the risks of CRS and neurological toxicities—remains essential to ensuring patient safety.

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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. From 2003 to 2023, 943 drugs were approved through the 505(b)(2) pathway. The 505(j) pathway is how you get a multisource generic. REFERENCE Soefje SA.