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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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IPA questions FAERS data interpretation in the Ohio State University study

Express Pharma

IPA also pointed out that US regulations require adverse events related to any dosage form of a drug to be reported under the same Abbreviated New Drug Application (ANDA) number, even if the product is manufactured at a different facility or outside India. Thus, it cannot be conclusively linked with the manufacturing site or manufacturers.

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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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Advanced Solutions for Sustained Delivery of Ocular Therapies

PharmaTech

While treatments for infection, inflammation, high eye pressure, and neovascularization have been shown to be effective, this method of delivery is considered “off-label,” as FDA has not approved products specifically for this use, except two intracameral implants (see below). Press Release, March 2, 2022. link] Cleveland Clinic.

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US eosinophilic oesophagitis market to reach $1.19bn by 2030

Pharmaceutical Technology

Dupixent, first approved for EoE in adults and adolescents in 2022 then expanded in 2024 to treat children as young as one, has quickly established itself as a first-line biologic due to its strong efficacy, favourable safety profile and biweekly subcutaneous administration.

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Drug Formulary App

RX Note

It is a quick reference for indication, dosage, availability and prescribing category. NOTE: The latest MOHMF database is 2022-3. Initiatives under Rx Note Rx via AppSheet or Caspio Rx & Calc via Open As App MOH Medicines Formulary (FUKKM) via Wistify Database last updated to MOHMF 2022-3.

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Co-trimoxazole in Pneumocystis Jiroveci Pneumonia

RX Note

Dosage Co-trimoxazole comes in both double-strength and single-strength tablets. NOTE: Co-trimoxazole is also used off-label for primary prophylaxis of toxoplasma Gondii encephalitis in patients with HIV. Mechanism of Action Both trimethoprim and sulfonamides inhibit bacterial folate synthesis, but at a different step in the pathway.