Rx Products
Table of Contents
Lumateperone (Caplyta)
From: Johnson & Johnson
Image credit: Arnell Koegelenberg/peopleimages.com | stock.adobe.com
The FDA approved lumateperone (Caplyta; johnson & Johnson) as an adjunct therapy with antidepressants for the treatment of adults with major depressive disorder. Lumateperone is an oral,onc-daily atypical antipsychotic drug that was previously approved as a monotherapy for adults with schizophrenia and depressive episodes associated with bipolar I or II disorder. Results from 2 phase 3 global, double-blind, placebo-controlled trials highlighted lumateperone’s efficacy and safety for this indication.
New Approvals & Launches: Menopause Treatment, Supplements & Generic Injectable
here’s a summary of recent pharmaceutical approvals and product launches, updated with verified facts as of November 26, 2023:
Prescription Product
Elinzanetant (Lynkuet)
From: Bayer
The FDA approved elinzanetant (lynkuet), a first-in-class dual neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist, for the treatment of moderate to severe vasomotor symptoms (VMS) – commonly known as hot flashes and night sweats – due to menopause. FDA Approval News Release
Elinzanetant works by acting within the brain’s thermoregulatory center to restore temperature balance disrupted during menopause. This approval is based on positive results from the Phase 3 OASIS trials (OASIS-1: NCT05042362, OASIS-2: NCT05099159, OASIS-3: NCT05030584), which demonstrated significant and sustained reductions in the frequency and severity of VMS, as well as improvements in sleep and overall menopause-related quality of life. Bayer Press Release
For more information: lynkuet-us.com
OTC Product
URO Metabolism + Probiotic
From: O Positiv Health
URO Metabolism + Probiotic is a daily dietary supplement designed to support women’s energy levels, manage cravings, reduce bloating, and aid in healthy weight management. The formula combines metabolic support ingredients with a targeted probiotic blend.
Key ingredients include:
* Chromium Picolinate: Supports appetite regulation and healthy blood glucose levels.
* Vitamin B12: Helps convert food into energy and supports overall energy metabolism.
* Caffeine and Green Coffee Extract: Boost metabolism, enhance focus, and contribute to weight management.
* Targeted Probiotic Blend: Includes Bifidobacterium lactis IDCC 4301, Akkermansia muciniphila, and Lactobacillus gasseri, selected for their roles in digestive comfort, reducing bloating, supporting gut health, and assisting with weight management.
For more information: opositiv.com
Generic Product
Risperidone Extended-Release Injectable Suspension
Compare to: Risperdal Consta Long-Acting Injection
From: Lupin
Lupin launched a risperidone extended-release injectable suspension in 25-mg,37.5-mg, and 50-mg single-dose vials. this product utilizes Lupin’s Nanomi subsidiary’s PrecisionSphere technology, a long-acting injectable delivery system. Lupin Press Release
The formulation is approved by the FDA for the treatment of adults with schizophrenia and for maintenance therapy in adults with bipolar I disorder, either alone or in combination with lithium or valproate. Lupin received 180-day competitive generic therapy exclusivity for this product.
For more information: lupin.com
Disclaimer: This information is for general knowledge and informational purposes only,and does not constitute medical advice.It is essential to consult with a qualified healthcare professional for any health concerns or before making any decisions related to your health or treatment.