FDA announced recalls of multiple lots of ScieGen Pharmaceuticals’ Irbesartan Tablets labeled as Westminster Pharmaceuticals and Golden State Medical Supply due to impurity

FDA announced recalls of multiple lots of ScieGen Pharmaceuticals’ Irbesartan Tablets 75mg, 150mg, and 300mg labeled as Westminster Pharmaceuticals and Golden State Medical Supply due to impurity; one lot of Promise Pharmacy’s Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile 3mL vials (small particulate in solution). Read More →

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REDUCE-IT™ cardiovascular outcomes study of Vascepa® (Icosapent Ethyl) capsules met primary endpoint

REDUCE-IT study met its primary endpoint demonstrating an approximately 25% relative risk reduction in major adverse CV events (MACE) in the intent-to-treat patient population with use of Vascepa 4 grams/day as compared to placebo. Patients enrolled had LDL-C between 41-100 mg/dL controlled by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides (TGs) between 150-499 mg/dL and either established cardiovascular disease or diabetes mellitus and at least one other CV risk factor. Read More →

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The Lancet: Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial

In patients with type 2 diabetes and cardiovascular disease, albiglutide (Tanzeum) was superior to placebo with respect to major adverse cardiovascular events. Evidence-based glucagon-like peptide 1 receptor agonists should therefore be considered as part of a comprehensive strategy to reduce the risk of cardiovascular events in patients with type 2 diabetes. Read More →

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Lilly's Emgality™ (galcanezumab-gnlm) Receives U.S. FDA Approval for the Preventive Treatment of Migraine in Adults

Eli Lilly – FDA has approved Emgality™ (galcanezumab-gnlm) 120 mg injection for the preventive treatment of migraine in adults. Emgality offers a once-monthly, self-administered, subcutaneous injection. Patients with commercial insurance are candidates to receive Emgality for up to 12 months free as part of Lilly's patient support program. Read More →

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Antares: FDA Approves Xyosted™ (Testosterone Enanthate) Injection for Testosterone Replacement Therapy in Adult Males

The FDA has approved XYOSTED™ (testosterone enanthate) injection and is the first FDA approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration with an easy-to-use, single dose, disposable QuickShot® auto injector.  XYOSTED™ is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Read More →

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Paratek: FDA Approves SEYSARA™ (Sarecycline) for the Treatment of Moderate to Severe Acne

FDA has approved SEYSARA™ (sarecycline) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. SEYSARA (sarecycline) is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties for the potential treatment of moderate to severe acne in the community setting. Read More →

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AHA: Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement From the American Heart Association

AHA – new statement includes recommendations for the diagnosis and treatment of resistant hypertension (elevated BP despite concurrent use of 3 antihypertensive drug classes). Recommendations include confirming adherence, excluding white-coat effect, evaluating lifestyle issues, detecting drug interactions, screening for secondary HTN, and using specific drug classes (long-acting thiazide-like diuretic, mineralocorticoid receptor antagonist, others with complementary mechanisms of action). Read More →

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OIG: Treatment Planning and Medication Monitoring Were Lacking for Children in Foster Care Receiving Psychotropic Medication

OIG – a new report from the Office of Inspector General showed that 34% of children in foster care who were treated with psychotropic medications did not receive treatment planning or medication monitoring as required. Up to 80% of children enter foster care with significant mental health needs and psychotropic medications may be effective, however, they can have serious side effects that require treatment planning mechanisms and effective medication monitoring. Read More →

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NC DHHS migrates the NC Controlled Substances Reporting System (CSRS) to a new software platform on September 19th

NC DHHS - migrated the NC Controlled Substances Reporting System (CSRS) to a new software platform on September 19th. Your existing CSRS account has automatically been transferred into the new software system, but you will need to reset your password. If you have any questions or concerns, please contact support directly at 855-962-4767. Read More →

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FDA approves the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

FDA – approved the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals. This expanded REMS now applies to immediate-release (IR) opioid analgesics in addition to extended-release and long-acting (ER/LA) opioids, which have been subject to REMS since 2012. The FDA also approved the new “Opioid Analgesic REMS Education Blueprint for Health Care Providers (HCP) Involved in the Treatment and Monitoring of Patients with Pain” that outlines the core HCP-facing educational messages for the Opioid Analgesic REMS. Read More →

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Teva Announces U.S. Approval of AJOVY™ (fremanezumab-vfrm) Injection, the First and Only Anti-CGRP Treatment with Both Quarterly and Monthly Dosing for the Preventive Treatment of Migraine in Adults

Teva - approved AJOVY (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults. AJOVY, a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor, is the first and only anti-CGRP treatment for the prevention of migraine with quarterly (675 mg) and monthly (225 mg) dosing options. Read More →

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JAMA: Receipt of Timely Addiction Treatment and Association of Early Medication Treatment With Retention in Care Among Youths With Opioid Use Disorder

JAMA –Just 1 of 21 adolescents younger than 18 years and 1 of 4 young adults aged 18 to 22 years received medication for opioid use disorder within 3 months of diagnosis. Youths who received MAT were much less likely to discontinue care (buprenorphine 42% less likely, naltrexone 46% less likely, methadone 68% less likely) compared with youths who received behavioral treatment only. Strategies to address the underuse of evidence-based medications for youths with OUD are urgently needed. Read More →

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