Tag: ANDA application

Generic Drug User Fee Amendments: How GDUFA Laws Speed Up FDA Review

Generic Drug User Fee Amendments: How GDUFA Laws Speed Up FDA Review
wayne Holloway in: Medications 24 December 2025

GDUFA laws let the FDA collect fees from generic drug makers to speed up approval of affordable medications. Since 2012, review times have dropped from years to months, helping millions access low-cost drugs faster.

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Lithium Carbonate Generics: What You Need to Know About Serum Levels
Lithium Carbonate Generics: What You Need to Know About Serum Levels

Lithium carbonate generics require strict serum level monitoring due to their narrow therapeutic index. Learn how brand switches, dosing, age, and kidney function affect safety and effectiveness in bipolar disorder treatment.

Published ON: 12 Dec
Soy Products and Thyroid Medication: How to Take Levothyroxine Without Interference
Soy Products and Thyroid Medication: How to Take Levothyroxine Without Interference

Learn how to take levothyroxine safely with soy products. Discover the right timing to avoid absorption issues and keep your thyroid levels stable without giving up tofu, soy milk, or edamame.

Published ON: 21 Dec
NSAIDs and Peptic Ulcer Disease: Understanding the Real Risk of Gastrointestinal Bleeding
NSAIDs and Peptic Ulcer Disease: Understanding the Real Risk of Gastrointestinal Bleeding

NSAIDs like ibuprofen and naproxen are common pain relievers, but they can cause serious stomach bleeding, especially in older adults or those with risk factors. Learn who’s most at risk, how to protect yourself, and what alternatives exist.

Published ON: 2 Dec
Hyponatremia from SSRIs: Low Sodium and Confusion Risk in Older Adults
Hyponatremia from SSRIs: Low Sodium and Confusion Risk in Older Adults

SSRIs can cause dangerous low sodium levels, especially in older adults, leading to confusion, falls, and hospitalization. Learn who’s at risk, which antidepressants are safest, and what steps to take to prevent this hidden side effect.

Published ON: 1 Dec
Desloratadine vs Loratadine: Which Antihistamine Is Better for Allergy Relief?
Desloratadine vs Loratadine: Which Antihistamine Is Better for Allergy Relief?

Desloratadine and loratadine are both non-sedating antihistamines for allergies, but desloratadine is stronger, longer-lasting, and better for congestion and kids under 2. Learn which one works best for your symptoms.

Published ON: 7 Dec

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