Tag: FDA approval

Phentermine/Topiramate Extended-Release Capsules (Qsymia) for Weight Loss

This 2013 review evaluates the efficacy and safety of phentermine/topiramate extended-release (PHEN/TPM ER) capsules, marketed as Qsymia, for obesity management. Clinical trials demonstrated significant weight loss ranging from 8.1% to 10.9% with mid to high doses, compared to 1.4% to 1.8% with placebo. PHEN/TPM ER also led to reductions in

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Resmetirom: The First Food and Drug Administration-Approved Medication for Nonalcoholic Steatohepatitis (NASH)

This 2025 review discusses the FDA approval of resmetirom (Rezdiffra), the first medication for noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced fibrosis (F2–F3). Resmetirom is a selective thyroid hormone receptor-beta (THR-β) agonist that reduces hepatic fat and inflammation. Clinical trials demonstrated significant improvements in NASH resolution and fibrosis reduction

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Brain amyloid imaging—FDA approval of florbetapir F18 injection

In 2012, the FDA approved florbetapir F18 (Amyvid), a radioactive diagnostic agent for positron emission tomography (PET) imaging to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment being evaluated for Alzheimer’s disease (AD) and other causes of cognitive decline. A negative scan indicates sparse to no neuritic

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Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire Disorder

Bremelanotide, a melanocortin receptor agonist, has been FDA-approved as an as-needed treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women. Clinical trials demonstrated statistically significant improvements in sexual desire and reductions in distress related to low libido, though the overall clinical benefit was considered modest. Administered via subcutaneous injection

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Compounded Bioidentical Hormones: Myths and Realities

This article explores the widespread use of compounded bioidentical hormone therapy (cBHT), highlighting the lack of rigorous scientific evidence supporting its safety and efficacy. It stresses the need for clinicians to guide patients toward FDA-approved treatments for menopausal symptoms rather than relying on unregulated compounded alternatives. The article emphasizes the

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