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
TECELRA
FDA Grants Accelerated Approval for Tecelra Cell Therapy for the Treatment of Synovial Sarcoma
August 01, 2024 — Adaptimmune Therapeutics plc announced U.S. Food and Drug Administration (FDA) accelerated approval of Tecelra (afamitresgene autoleucel) for,
- the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy,
- who are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive, and
- whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- Tecelra is the first engineered cell therapy for a solid tumor cancer approved in the U.S.
- It is the first new therapy option in more than a decade for synovial sarcoma, a rare, soft tissue cancer that most commonly impacts young adults.
- Tecelra uses each patient’s own immune cells to recognize and attack their cancer cells in a one-time infusion treatment and is significantly different than the current standards of care for advanced synovial sarcoma.
Source: Adaptimmune Therapeutics plc
ZUNVEYL
FDA Approves Zunveyl for the Treatment of Alzheimer’s Disease
July 29, 2024 – Alpha Cognition has announced that the U.S. Food and Drug Administration (FDA) has granted approval for Zunveyl (benzgalantamine) previously known as ALPHA-1062, for the treatment of mild-to-moderate Alzheimer’s disease.
- Zunveyl, a novel oral therapy, has a dual mechanism of action designed to eliminate drug absorption in the GI tract, potentially addressing certain tolerability issues with leading AD medications, combined with the efficacy and long-term benefit profile of galantamine.
Source: Alpha Cognition
ERZOFRI®
FDA Approves Erzofri for the Treatment of Schizophrenia and Schizoaffective Disorder
July 28, 2024 – Luye Pharma Group announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Erzofri (paliperidone palmitate) extended-release injectable suspension, for treating schizophrenia in adults and for treating schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants.
- Erzofri, administered once a month, is the first patented paliperidone palmitate long-acting injection developed in China to get approved in the U.S.
- Antipsychotic medications are used to treat and control symptoms of schizophrenia and schizoaffective disorder, but patient adherence to antipsychotics is generally poor. The use of long-acting injectable (LAI) antipsychotics is effective in improving patient adherence.
- Erzofri is not approved for use in patients with dementia-related psychosis, and the safety and effectiveness of Erzofri in pediatric patients have not been established.
Source: Luye Pharma Group
LEQSELVI
FDA Approves Leqselvi, an Oral JAK Inhibitor, for the Treatment of Severe Alopecia Areata
July 26, 2024 – Sun Pharmaceutical Industries Limited announced that the U.S. Food and Drug Administration (FDA) approved Leqselvi (deuruxolitinib) 8mg tablets for the treatment of adults with severe alopecia areata.
- The recommended dosage of Leqselvi for the treatment of severe alopecia areata is 8mg orally twice daily, with or without food.
- Leqselvi is contraindicated in patients who are CYP2C9 poor metabolizers or who are using moderate or strong CYP2C9 inhibitors. Also, Leqselvi is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
Source: Sun Pharma
FEMLYV
FDA Approves Femlyv Orally Disintegrating Birth Control Pill
July 22, 2024 – the U.S. Food and Drug Administration (FDA) approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy.
- Norethindrone acetate and ethinyl estradiol, the main ingredients in Femlyv, have been approved in the U.S. for the prevention of pregnancy as a swallowable tablet since 1968.
- Femlyv is the first FDA-approved dissolvable birth control pill, designed for individuals who have trouble swallowing their medication.
Source: FDA
Biosimilars
EPYSQLI
FDA Approves Epysqli, a Biosimilar to Soliris
July 22, 2024 – Samsung Bioepis Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Epysqli (eculizumab-aagh) infusion as a biosimilar to Soliris (eculizumab).
- Epysqli has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria(PNH) to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.
- Epysqli is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).
Source: Samsung Bioepis Co., Ltd..
Generic Drug Approvals
- Indium In-111 Pentetreotide Injection Kit3 mCi/mL
Approved: July 1, 2024 – Sun Pharmaceutical Industries, Inc.
Used for: Diagnosis and Investigation
Generic for: Octreoscan - Bupivacaine Liposome Injectable Suspension133mg/10mL (13.3mg/mL) and 266mg/20mL (13.3mg/mL)
Approved: July 1, 2024 – Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Used for: Analgesia
Generic for: Exparel - L-Glutamine Powder for Oral Solution5gm/packet
Approved: July 8, 2024 – Novitium Pharma LLC
Used for: Sickle Cell Disease
Generic for: Endari - Nimodipine Oral Solution3mg/mL
Approved: July 9, 2024 – Annora Pharma Private Limited
Used for: Subarachnoid Hemorrhage
Generic for: Nymalize - Tazarotene Topical Cream05%
Approved: July 15, 2024 – Padagis Israel Pharmaceuticals Ltd.
Used for: Plaque Psoriasis
Generic for: Tazorac Cream 0.05%
Recalls
Endo USA, Inc. Issues Recall of One Lot of Clonazepam Orally Disintegrating Tablets Due to Mislabeling: Incorrect Strength on Product Carton
July 16, 2024 – Endo, Inc announced that one of its operating subsidiaries, Endo USA, Inc., is voluntarily recalling one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25mg tablets, which may also appear as Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg tablets 60-count pack to the consumer level.
The product lot is being recalled due to mislabeling where an incorrect strength appears on the cartons of some packs to show the product strength as 0.125mg and not 0.25mg due to an error at a third-party packager. The blister strips inside the product pack reflect the correct strength of 0.25mg.
This recall impacts the following product lot:
- Correct carton label: Clonazepam Orally Disintegrating Tablets, USP 0.25mg 60-count carton, lot 550147301, expiration date August 2026
- Incorrect carton label: Clonazepam Orally Disintegrating Tablets, USP 0.125mg 60-count carton, lot 550147301, expiration date August 2026
(Note: No BeneCard PBF members were affected by this recall.)
Source: FDA
Main Products, Inc. Issues Recall of Umary Acido Hialuronico, Suplemento Alimenticio Due to the Presence of Undeclared Drug Ingredients
July 22, 2024 – Main Products, Inc. is voluntarily recalling all lots of “Umary Acido Hialuronico, Suplemento Alimenticio – 30 Capletas de 850mg” to the consumer level. FDA laboratory analysis confirmed that UMARY has been found to be tainted with the drug ingredients, diclofenac and omeprazole. Products containing diclofenac and omeprazole cannot be marketed as dietary supplements. UMARY is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.
Risk Statement: Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). There is a reasonable probability that consumption of high levels of undeclared diclofenac could result in serious adverse events that include cardiovascular, gastrointestinal, renal, and anaphylaxis in patients taking concomitant NSAIDs and/or anticoagulants, such as Warfarin, in those who have allergies to diclofenac, or those with underlying cardiovascular, gastrointestinal, renal, and hepatic illnesses.
Omeprazole is a proton pump inhibitor (commonly referred to as PPI) used to treat gastric (stomach) acid-related disorders. PPI medicines may cause serious skin reactions, abdominal pain, diarrhea, nausea, and headache. This hidden ingredient may mask stomach issues such as erosions, ulcers, and stomach cancer, and it can also interact with other medications and should not be taken with certain medications.
The product is used as a dietary supplement promoted and sold for pain and is packaged in bottles with 30 caplets. The affected product includes all lots within expiry. The product was distributed via online store Main Products, Inc. on Amazon.com.
Main Products, Inc. is notifying its customers by email and is arranging for the return of all recalled products. Consumers that have UMARY which is being recalled should stop using and return to their place of purchase. Consumers may return the products to the address below.
Main Products, Inc., 1551 Glenwood Springs Ave., Chula Vista CA, 91913