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
RYTELO™
FDA Approves Rytelo for the Treatment of Adult Patients with Lower-Risk MDS with Transfusion-Dependent Anemia
June 6, 2024 – Geron Corporation has announced that the U.S. Food and Drug Administration (FDA) has approved Rytelo™ (imetelstat) for the treatment of adult patients:
- with low- to intermediate-1 risk myelodysplastic syndromes (MDS),
- with transfusion-dependent (TD) anemia requiring four or more red blood cell units over eight weeks,
- who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).
Rytelo is a first-in-class treatment that works by inhibiting telomerase enzymatic activity, and It is indicated to be administered as an intravenous infusion over two hours every four weeks.
Source: Geron Corporation
mRESVIA®
FDA Approves mRESVIA for Prevention of Lower Respiratory Tract Disease Caused by RSV
May 31, 2024 – The FDA has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.
- The approval was granted under a breakthrough therapy designation and marks the second approved mRNA product from Moderna. The vaccine uses the same lipid nanoparticles (LNPs) as the Moderna COVID-19 vaccines.
- Moderna expects to have mRESVIA available for eligible populations in the U.S. by the 2024/2025 respiratory virus season.
Source: Moderna, Inc.
ONYDA XR
FDA Approves Onyda XR Non-Stimulant Liquid Treatment for ADHD
May 29, 2024 – The FDA has approved Onyda XR (clonidine hydrochloride), a once-a-day extended-release oral suspension with nighttime dosing, for the treatment of ADHD as a monotherapy or as an adjunctive therapy to approved central nervous system (CNS) stimulant medications in pediatric patients six years and older.
- The FDA approval of Onyda XR is based on adequate and well-controlled studies of clonidine hydrochloride extended-release tablets.
- Onyda XR is the first non-stimulant ADHD medication in Tris’ portfolio, the first-and-only liquid non-stimulant ADHD medication approved in the United States and the only approved non-stimulantADHD medication with nighttime dosing.
- Tris Pharma harnessed the flexibility of its proprietary LiquiXR® technology to develop Onyda XR, a liquid non-stimulant medication with a smooth, extended-release profile that physicians can use to treat ADHD patients either alone or in combination with stimulant therapy.
Source: Tris Pharma News and Media
IMDELLTRA™
FDA Grants Accelerated Approval for Imdelltra for the Treatment of Extensive-Stage Small Cell Lung Cancer
May 16, 2024 – The FDA has approved Imdelltra™ (tarlatamab-dlle), manufactured by Amgen, for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
- Imdelltra is the first and only DLL3-targeting Bispecific T-cell Engager therapy that activates the patient’s own T cells to attack DLL3-expressing tumor cells.
- Imdelltra is administered as an intravenous infusion over one hour in an appropriate hospital setting.
Source: Amgen
MYHIBBIN™
FDA Approves Myhibbin Oral Suspension for Prophylaxis of Organ Rejection
May 6, 2024 – Azurity Pharmaceuticals, has announced that the FDA has approved Myhibbin, the only ready-to-use mycophenolate mofetil oral suspension. Mycophenolate mofetil is an antimetabolite immunosuppressant used to protect a donated organ from being rejected from the body’s immune response.
- In 2023, there were over 46,000 transplants in the US and these patients need to take medication every day to fight against rejection.
- Myhibbin is indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart, or liver transplants, in combination with other immunosuppressants.
- It is expected that Myhibbin will become commercially available in pharmacies nationwide in Q2 2024.
Source: Azurity Pharmaceuticals, Inc.
Generic Drug Approvals
- Edaravone Intravenous Solution 30 mg/100 mL and 60 mg/100 mL
Approved: May 6, 2024 – Gland Pharma Limited; Hikma Pharmaceuticals USA Inc. (30 mg/100 mL only); Long Grove Pharmaceuticals, LLC (30 mg/100 mL only); Dr. Reddy’s Laboratories Limited (60 mg/100 mL only)
Treatment for: Amyotrophic Lateral Sclerosis
Generic for: Radicava - Emtricitabine and Tenofovir Alafenamide Fumarate Tablets 120 mg/15 mg (base) and 200 mg/25 mg (base)
Approved: May 17, 2024 – Apotex Corp.
Treatment for: HIV Infection
Generic for: Descovy - Halcinonide Topical Solution 0.1%
Approved: May 29, 2024 – Encube Ethicals Private Limited
Treatment for: Inflammatory Skin Diseases
Generic for: Halog Solution
Biosimilars
FDA Approves Bkemv, an Interchangeable Biosimilar to Soliris
May 28, 2024 – The FDA has approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. As an interchangeable biosimilar, Bkemv is highly similar with no clinically meaningful differences to Soliris.
- Bkemv is approved for the following treatment indications, which are also currently approved for Soliris:
-
- the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis; and
- the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.
- Bkemv is available only through a restricted program called the Bkemv Risk Evaluation and Mitigation Strategy (REMS).
Source: FDA
FDA Approves Yesafili and Opuviz as Interchangeable Biosimilars to Eylea
May 20, 2024 – The FDA has approved Yesafili (aflibercept-jbvf), an interchangeable biosimilar to Eylea (aflibercept). Aflibercept products work by inhibiting vascular endothelial growth factor (VEGF) which prevents abnormal blood vessel growth within the eye.
The FDA also approved Opuviz (aflibercept-yszy), an interchangeable biosimilar to Eylea (aflibercept).
Both Yesafili and Opuviz are the first interchangeable biosimilars to Eylea to treat certain eye conditions. They are used to treat:
- Neovascular (wet) age-related macular degeneration
- Macular edema following retinal vein occlusion
- Diabetic macular edema
- Diabetic retinopathy
Source: FDA
Recalls
Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Docetaxel Injection, USP Due to Potential Presence of Particulate Matter
May 28, 2024 – Sagent Pharmaceuticals as announced the voluntary nationwide recall of two lots of Docetaxel Injection, USP (80 mg per 8 mL multi-dose vials and 160 mg per 16 mL multi-dose vials). The product was distributed by Sagent Pharmaceutical, and the company has initiated a voluntary recall.
The Docetaxel Injection, USP, label and affected lot numbers with Expiration Dates and NDC number can be found in the table below. Product was distributed Nationwide from October 11, 2023, to April 11, 2024.
| Product | Lot Number | NDC | Expiration Date | Strength |
| DOCETAXEL INJECTION, USP |
F1030001
F1040001 |
25021-254-16
25021-254-08 |
12/2024
12/2024 |
160 mg/16 mL (10 mg/mL)80 mg/8 mL (10 mg/mL) |
Source: FDA
HomeoCare Laboratories Inc. Issues Recall of Stella Life Oral Care Spray Unflavored and Advanced Formula Peppermint Oral Care Rinse Due to Microbial Contamination
June 5, 2024 – HomeoCare Laboratories Inc. is voluntarily recalling two batches of Homeopathic StellaLife Oral Care Products listed in the table below manufactured in 2024 due to FDA findings of microbial contamination. This recall is to be performed at the consumer level.
Risk Statement: The following two (2) products listed below were found to contain higher than acceptable levels of TAMC (found in the StellaLife Advanced Formula Peppermint Vega Oral Care Rinse) and Bacillus sp (found in the StellaLife Vega Oral Spray, Unflavored).
| Production Date | Release Date | Customers | Product Name | NDC | Lot No. | Expiration Date |
| 02/16/2024 | 03/28/2024 | StellaLife Inc. | StellaLife VEGA Oral Care, Spray Unflavored | 69685-121-01 | 2552 | 02-2026 |
| 03/01/2024 | 03/28/2024 | StellaLife Inc. | StellaLife Advanced Formula Peppermint VEGA Oral Care Rinse | 69685-143-16 | 2550 | 02-2026 |
Source: FDA