BeneCard PBF compiles the latest pharmacy news from across the web, including new drug approvals, recalls, new generic drug approvals and more. The content is the property of the website owners, writers and contributors.
New Drug Approvals
RISVAN®
FDA Approves Risvan (risperidone) for the Treatment of Schizophrenia
April 2, 2024 – Laboratorios Farmacéuticos ROVI, S.A. has announced that the U.S. Food and Drug Administration (FDA) has authorized the marketing of Risvan® (Risperidone ISM®) for the treatment of schizophrenia in adults.
Risperidone ISM® is a prolonged-release injectable antipsychotic developed and patented by ROVI for the treatment of schizophrenia in adults, which, as of the first injection, provides immediate and sustained plasmatic drug levels and does not require loading doses or supplementation with oral risperidone.
Schizophrenia is a chronic, serious, and disabling mental disorder that affects around 1% of the world population. Schizophrenia patients are characterized by a mixture of symptoms, both positive (delusional ideas, hallucinations, disorganized language, and behavior) and negative (affective flattening, speech poverty, apathy) in nature. It is estimated that between 3% and 5% of total global healthcare expenditure is spent on schizophrenia.
VOYDEYA
FDA Approves Voydeya as Add-On Therapy for the Treatment of Extravascular Hemolysis in Paroxysmal Nocturnal Hemoglobinuria
April 1, 2024 – Voydeya (danicopan) has been approved in the U.S. as add-on therapy to ravulizumab (Ultomiris) or eculizumab (Soliris) which are 5 inhibitors, for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH). Voydeya is a first-in-class, oral, Factor D inhibitor developed as an add-on to standard-of-care Ultomiris (ravulizumab-cwvz) or Soliris (eculizumab) to address the needs of the approximately 10-20% of patients with PNH who experience clinically significant EVH while treated with a C5 inhibitor.
Voydeya is a prescription medicine used along with ravulizumab or eculizumab to treat breakdown of red blood cells that takes place outside of blood vessels (extravascular hemolysis), in adults with paroxysmal nocturnal hemoglobinuria (PNH).
VAFSEO®
FDA Approves Vafseo for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients on Dialysis
March 27, 2024 – AkebiaTherapeutics, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Vafseo® (vadadustat) Tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Vafseo is a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin to manage anemia. Vafseo is now approved in 37 countries.
Approximately 500,000 adult patients in the U.S. on dialysis suffer from anemia due to CKD, which may be associated with many adverse clinical outcomes. The burden of managing uncontrolled anemia in CKD patients can be substantial, both in terms of healthcare costs and the impact on patients, healthcare providers, and caregivers.
WINREVAIR™
FDA Approves Winrevair a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension
March 26, 2024 – Merck announced that the U.S. Food and Drug Administration (FDA) has approved sotatercept-csrk (U.S. Brand Name: Winrevair™), for injection, 45mg, 60mg for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events. Winrevair was previously granted Breakthrough Therapy Designation by the FDA. Winrevair is the first FDA-approved activin signaling inhibitor therapy for PAH, representing a new class of therapy that works by improving the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation underlying PAH.
The approval is based on the Phase 3 STELLAR trial, which compared Winrevair (n=163) to placebo (n=160), both in combination with background standard of care therapies in adult patients with PAH (WHO Group 1 FC II or III).
Healthcare providers should monitor hemoglobin and platelets before each dose of Winrevair for the first five doses, or longer if values are unstable, and periodically thereafter to determine if dose adjustments are required. Winrevair may increase hemoglobin and may lead to erythrocytosis, which if severe may increase the risk of thromboembolic events or hyperviscosity syndrome. Winrevair also may decrease platelet count and lead to severe thrombocytopenia, which may increase the risk of bleeding; thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Treatment should not be initiated if platelet count is <50,000/mm.
Winrevair is given once every three weeks by subcutaneous injection and may be administered by appropriate patients or caregivers with guidance, training, and follow-up from a healthcare provider. Healthcare providers and patients/caregivers should refer to the Instructions for Use for information on the proper preparation and administration of Winrevair. Merck estimates that Winrevair will be available for dispensing by select specialty pharmacies in the U.S. by the end of April 2024.
OPSYNVI®
FDA Approves Opsynvi (macitentan and tadalafil) for Adults with Pulmonary Arterial Hypertension
March 22, 2024 – Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Opsynvi® – a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor – for the chronic treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group I) and WHO functional class (FC) II-III. Opsynvi® may be used in patients with PAH who are treatment-naïve or who are already on an ERA, PDE5 inhibitor or both. Opsynvi® may be used in patients who are currently treated concomitantly with stable doses of macitentan 10mg and tadalafil 40mg (20mg x 2) as separate tablets.
With the approval, Johnson & Johnson now offers a PAH portfolio addressing all three foundational and guideline-recommended pathways – nitric oxide, endothelin, and prostacyclin.
The 2022 European Society of Cardiology (ESC)/European Respiratory Society (ERS) clinical guidelines recommend initial combination therapy of an ERA and a PDE5 inhibitor for patients with idiopathic PAH, heritable drug-associated PAH, or PAH-associated with connective tissue disease without cardiopulmonary comorbidities at low or intermediate risk.
Individually, macitentan reduces the risk of clinical worsening events and hospitalization, and tadalafil improves exercise ability.
DUVYZAT™
FDA Approves Duvyzat for Duchenne Muscular Dystrophy
March 22, 2024 – Italfarmaco S.p.A. announced that the U.S. Food and Drug Administration (FDA) has approved Duvyzat™ (givinostat), a novel histone deacetylase (HDAC) inhibitor, for the treatment of patients 6 years or older with Duchenne muscular dystrophy (DMD), a rare X-linked progressive and life-limiting neuromuscular condition with symptoms from early childhood.
DMD is a severe neuromuscular genetic disease characterized by progressive muscle weakness and degeneration and is the most common type of muscular dystrophy globally. DMD is caused by mutations in the dystrophin gene that result in the absence of a functional dystrophin protein.
Duvyzatan oral suspension, received priority review, orphan drug, and rare pediatric disease designations from the FDA. A Marketing Authorization Application (MAA) for givinostat as a potential treatment for DMD has been submitted to the European Medicine Agency (EMA) and is currently under review.
TRYVIO™
FDA Approves Tryvio for the Combination Treatment of Resistant Hypertension
March 20, 2024 – Idorsia Pharmaceuticals U.S. Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Tryvio™ (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. The recommended dosage of Tryvio is 12.5mg orally once daily, with or without food.
Tryvio (aprocitentan) is an endothelin receptor antagonist that inhibits the binding of endothelin (ET)-1 to ETA and ETB receptors. The effects of ET-1 bear many similarities with the pathophysiology of hypertension, and ET-1 is a major driver of aldosterone production. Until the approval of Tryvio, no systemic antihypertensive medications targeted the ET pathway, as approved antihypertensive therapies focus on the regulation of salt and water (diuretics), antagonism of the renin–angiotensin–aldosterone (RAAS) system, reduction of influx of extracellular calcium into the cell (calcium channel blockers), sympatholytic activity (beta blockers, central alpha-agonist agents), or non-selective vasodilatory effects.
Tryvio is available only through a restricted program under a REMS called the Tryvio REMS because of the risk of embryo-fetal toxicity. Prescribers must be certified with the Tryvio REMS by enrolling and completing training. Pharmacies that dispense Tryvio must be certified with the Tryvio REMS.
LENMELDY™
FDA Approves Lenmeldy for Children with Metachromatic Leukodystrophy
March 18, 2024 – Orchard Therapeutics/Kyowa Kirin has announced the U.S. Food and Drug Administration (FDA) has approved Lenmeldy™, formerly known as OTL-200, for the treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ) or early symptomatic early juvenile (ESEJ)—collectively referred to as early-onset—metachromatic leukodystrophy (MLD).
Metachromatic leukodystrophy is a rare and severe genetic condition that affects the brain and nervous system. Metachromatic leukodystrophy is caused by a faulty gene, which means that the body does not make enough of an enzyme called arylsulfatase A (ARSA). That lack of ARSA causes fatty substances called sulfatides to build up in the brain and nerves, leading to problems with movement and thinking abilities, severe spasticity, seizures, and patients gradually losing the ability to move, talk, swallow, eat, and see.
Lenmeldy is a gene therapy used to treat types of metachromatic leukodystrophy in children. Lenmeldy is made using the patient’s own stem cells that have been modified so that the body can make the ARSA enzyme to help stop the progression of MLD. Lenmeldy is given as a one-time infusion.
REZDIFFRA
FDA Grants Accelerated Approval for Rezdiffra for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
March 14, 2024 – Madrigal Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Rezdiffra (resmetirom) in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Continued approval for this indication may be contingent upon verification and description of clinical benefits in ongoing confirmatory trials.
Rezdiffra is a once-daily, oral THR-beta agonist designed to target key underlying causes of NASH. The accelerated approval of Rezdiffra was based on results from the Phase 3 MAESTRO-NASH trial, which was recently published in the New England Journal of Medicine.
The Rezdiffra prescribing information does not include a liver biopsy requirement for diagnosis. Rezdiffra should not be used in patients with decompensated cirrhosis.
TEVIMBRA
FDA Approves Tevimbra for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma
March 13, 2024 – BeiGene, Ltd., has announced that the U.S. Food and Drug Administration (FDA) has approved Tevimbra (tislelizumab-jsgr) as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
Approval is based on the RATIONALE 302 trial, which met its primary endpoint in the intention-to-treat (ITT) population with a statistically significant and clinically meaningful survival benefit for Tevimbra compared with chemotherapy, highlighting its potential as an important treatment option for these patients.
Tevimbra is an IV injection and will be available in the U.S. in the second half of 2024.
Generic Drug Approvals
- Finasteride and Tadalafil Capsules 5mg / 5mg
Approved: March 15, 2024 – Zydus Worldwide DMCC
Treatment for: Benign Prostatic Hyperplasia
Generic for: Entadfi
Recalls
Eugia US LLC (f/k/a AuroMedics Pharma LLC) Issues Voluntary Nationwide Recall of Methocarbamol Injection, USP 1000mg/10mL (100mg/mL) (Single-Dose Vial) Due to Presence of White Particles
March 28, 2024 – Eugia US LLC (f/k/a AuroMedics Pharma LLC) has initiated a voluntary recall of lot number 3MC23011 of Methocarbamol Injection, USP 1000mg/10mL (100mg/mL) (Single Dose Vial) – 10mL Vial to the consumer level due to a customer product complaint for the presence of white particles floating inside of the vial.
Risk Statement: Administration of an injectable product that contains particulate matter may result in local irritation or swelling. If the particulate matter reaches the blood vessels or is injected intravascularly it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Eugia US LLC has not received any reports of adverse events related to this recall.
The product can be identified by product name on carton and vial label and with lot number 3MC23011 and Exp. Date: Nov 2026 (NDC 55150-223-10).
Eugia US LLC (f/k/a AuroMedics Pharma LLC) is notifying its distributors by recall letters and is arranging for the return/replacement of all recalled products. Wholesalers, hospitals, pharmacies, institutions, and doctors with an existing inventory of the recalled product lot should discontinue use, stop distribution, and quarantine the product immediately. If you have further distributed the recalled product lot, notify your accounts and/or any additional locations which may have received the recalled product. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall.
Consumers with medical questions regarding this recall or to report an adverse event can contact Eugia US LLC from 8:00 am to 5:00 pm (EST) Monday – Friday at:
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- 1-866-850-2876 Option 2
- pvg@aurobindousa.com
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Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
If you have any general questions regarding the return of this product, please contact Qualanex at 1-800-505-9291 or email recall@qualanex.com (live calls received 7:00am to 4:00pm M-F CST).
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
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- Complete and submit the report online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Source: FDA
Amneal Pharmaceuticals, LLC. Issues a Nationwide Voluntary Recall of Vancomycin Hydrochloride for Oral Solution USP, 250mg/5mL, Due to the Potential for Some Bottles to be Super Potent Which May be Harmful
March 27, 2024 – Amneal Pharmaceuticals, LLC., has voluntarily recalled four lots (see table on following page) of Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL packaged in 80mL, 150mL, or 300mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can result in an over potent dosing regimen. The recommended maximum daily dose allowance for this product is up to 2gm/day and patients prescribed a dosing regimen of 500mg/10mL would exceed this daily allowance, which may be harmful to patients with renal insufficiency. The error occurred during the manual bottle filling stage of manufacturing.
Risk Statement: Adult patients who are prescribed the maximum daily dose of up to 2 grams per day of Vancomycin Hydrochloride for oral solution, USP 250 mg/5mL, may receive up to 4 grams of oral vancomycin per day because of the overfilled bottle. Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin. These patients may be at risk for the development of adverse reactions associated with higher doses of vancomycin oral solution. Worsening renal function could be associated with electrolyte abnormalities such as high potassium leading to cardiac arrest. To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.
Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL
| NDC No. | Lot | Expiration Date | Pack Size |
| 69238-2261-3 | 22613003A | 09/2025 | 80mL |
| 69238-2261-7 | 22613004A | 09/2025 | 150mL |
| 69238-2261-7 | 22613005A | 09/2025 | 150mL |
| 69238-2261-5 | 22613005B | 09/2025 | 300mL |
The affected Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL lots were distributed Nationwide in the USA directly to Wholesalers and Distributors. The Lots were distributed between 11/09/2023 and 2/20/2024.
Amneal is notifying its direct customers via mail (UPS Standard Overnight) by mailing a recall notification letter and is arranging for the return of the recalled products. Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately.
Customers who purchased the impacted product directly from Amneal may call Amneal at 1-833-582-0812 Monday – Friday, 8:00am – 5:00pm, EST, or email to Vancomycin_Recall@amneal.com for further information.
Consumers who have Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/mL should examine the bottle, cease using the product if the lot number is listed on the recall and contact Amneal via telephone or email for recall information and for product return instructions. Consumers may call Amneal at 1-833-582-0812 Monday – Friday, 8:00 am – 5:00 pm, EST, or email Vancomycin_Recall@amneal.com for further information and instructions for the product return. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
If you would like to report any adverse reactions or quality problems experienced with the use of this product you may contact Amneal Drug Safety by phone at 1-877-835-5472, Monday – Friday, 8:00 am – 6:00 pm, EST, or via e-mail at DrugSafety@amneal.com.
Any adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
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- Complete and submit the report Online.
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
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Source: FDA