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The Saffron book: An orange book of India

Express Pharma

This article explores the necessity for such a resource, an Indian equivalent of the Orange Book, examining its potential benefits and far-reaching sector-wide impacts across the healthcare and pharmaceutical sectors. Clear marking of innovator and approved generic products.

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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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LENZ Therapeutics’ Presbyopia Treatment VIZZ Receives FDA Approval in the U.S.

PharmExec

This demonstrated Vizz’s ability to improve near sighted vison within 30 minutes of dosage, with an active timeframe upwards of 10 hours. Author(s): Nicholas Jacobus Key Takeaways Vizz, an aceclidine-based eye drop, is FDA-approved for presbyopia, enhancing near vision without myopic shifts.

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FDA Mandates Safety Alterations to Opioid Pain Medication Labels

PharmExec

New labels will include study summaries, improved dosage warnings, and information on overdose reversal agents to enhance patient and healthcare professional awareness. New labels will include study summaries, improved dosage warnings, and information on overdose reversal agents to enhance patient and healthcare professional awareness.

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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. For submission consideration, manufacturers can petition the FDA for ANDA status if the requested change does not require safety or effectiveness studies.

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Lumateperone Submits Application for Schizophrenia Indication to FDA for Supplemental New Drug

Pharmacy Times

2 Guiding prescribers and patients through initiation of lumatperone, adjusting dosage amounts, and switching from other antipsychotics, emphasizing its favorable relapse reduction profile is key in preventing relapse. 1-3 REFERENCES 1. Johnson & Johnson.