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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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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.

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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

REMS ensured drug safety by requiring certified hospitals to have tocilizumab for severe adverse events management. Increased experience in managing CAR T therapy toxicities has led to the removal of REMS, facilitating broader access.

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Once-Daily Alixorexton Improves Wakefulness at All Doses in Patients With Narcolepsy Type 1

Pharmacy Times

In a sign of alixorexton’s tolerability, over 95% of patients who participated in this portion of the trial elected to join the ongoing 7-week, open-label extension.

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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 the 505(j) ANDA approval pathway, on the other hand, submissions can be multisource generic drugs; however, this pathway requires bioequivalence to the RLD.