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Lupin Receives FDA Approval for Generic Rivaroxaban Tablets for Thrombosis Prevention

FDA Approval
  • Lupin has received U.S. FDA approval for its generic version of Rivaroxaban Tablets, expanding its cardiovascular portfolio with a key anticoagulant medication.
  • Rivaroxaban is primarily indicated for the prevention and treatment of deep vein thrombosis, pulmonary embolism, and stroke prevention in patients with atrial fibrillation.
  • The approval represents a significant milestone for Lupin in the competitive generic pharmaceutical market, potentially offering a more affordable alternative to Janssen's branded Xarelto.

Caplin Steriles Receives USFDA Approval for Generic Haloperidol Decanoate Injection

FDA Approval
  • Caplin Steriles, a subsidiary of Caplin Point Laboratories, has received final USFDA approval for its generic version of Haloperidol Decanoate Injection, used for treating schizophrenia patients requiring long-term antipsychotic therapy.
  • The approved product comes in multiple formulations including 50mg/mL and 100mg/mL single-dose vials and 500mg/5mL multiple-dose vials, equivalent to Janssen Pharmaceuticals' HALDOL injection.
  • According to IQVIA data, Haloperidol Decanoate Injection generated approximately $16.4 million in US sales for the 12-month period ending March 2025, representing a significant market opportunity.

FDA Approves Miplyffa for Niemann-Pick Type C Disease, Offering New Hope for Rare Genetic Disorder

Drug ApprovalRare DiseaseOrphan DrugFDA Approval
  • The FDA has approved Miplyffa, a new medication for treating Niemann-Pick Type C (NPC), a fatal genetic disorder affecting approximately 900 people in the United States.
  • Miplyffa works by protecting cells from fat accumulation and slowing disease progression, helping patients maintain neurological function for longer periods.
  • The drug is approved for children over two years old and has shown promising results in early patients, with some experiencing stabilization or improvement in disease markers within three months.
  • NPC is a progressive disorder that typically robs patients of their ability to speak, think clearly, swallow, walk, and move, often affecting children and young adults.

Catheter Precision Acquires Cardionomic's Heart Failure Technology for Novel Neuromodulation Therapy

FDA Approval
• Catheter Precision completed acquisition of Cardionomic's heart failure assets through its 82% owned subsidiary, expanding into acute decompensated heart failure treatment. • The acquired CPNS System uses electrical stimulation via pulmonary artery catheter to target autonomic cardiac nerves, addressing over 1 million annual U.S. hospitalizations for ADHF. • Initial pilot studies showed positive results for the neuromodulation therapy, though the company acknowledges significant development challenges and regulatory hurdles ahead. • The acquisition represents a strategic expansion beyond Catheter Precision's core cardiac electrophysiology focus into the broader heart failure treatment market.

CML Treatment Market Poised for Significant Growth Through 2032 Amid Wave of Recent FDA Approvals

OncologyDrug ApprovalFDA Approval
  • The chronic myelogenous leukemia treatment market is expected to experience significant growth through 2032, driven by increasing disease prevalence and multiple recent FDA approvals.
  • Recent regulatory milestones include FDA approvals for Cipla's nilotinib capsules, Marks Shorla's oral liquid imatinib formulation, and Novartis's accelerated approval for Scemblix in newly diagnosed patients.
  • The market features a robust pipeline of emerging therapies from companies including Enliven Therapeutics, Terns Pharmaceuticals, and Ascentage Pharma targeting unmet needs in resistant cases.
  • Current epidemiological data shows approximately 9,280 new CML diagnoses expected in the US in 2024, with 85-90% of patients diagnosed during the chronic phase.

GENinCode Faces FDA Hurdles in De Novo Submission for Cardiovascular Genetic Risk Assessment

FDA Approval
  • GENinCode received FDA feedback on its De Novo submission identifying outstanding deficiencies, particularly in clinical validation requirements.
  • The company initiated a Supervisory Review with the FDA, which reduced the number of outstanding issues but upheld the agency's position on remaining elements.
  • The Board believes it can address all outstanding elements through ongoing discussions with the FDA, though no certainty exists that the information will be sufficient.
  • A further update will be provided at the Preliminary Results at the end of May 2025.

FDA-Approved Lenire Device Shows 91.5% Success Rate in Real-World Tinnitus Treatment Study

FDA ApprovalReal World EvidenceNeurology
• A new study published in Nature Communications Medicine reveals that 91.5% of tinnitus patients experienced clinically meaningful improvement after 12 weeks of treatment with the Lenire bimodal neuromodulation device.
• The retrospective analysis of 220 patients represents one of the largest real-world studies of tinnitus treatment, confirming results from previous clinical trials that led to FDA approval in March 2023.
• Lenire works by simultaneously delivering audio tones through headphones and mild electrical pulses to the tongue, offering a promising treatment option for the estimated 25 million Americans suffering from tinnitus.

FDA Approves 25 First-Time Generic Drugs in First Half of 2025, Expanding Access to Critical Therapies

FDA ApprovalDrug ApprovalOncology
  • The FDA approved 25 first-time generic drugs in the first six months of 2025, including generics for critical medications treating HIV, cancer, and neurological conditions.
  • Notable approvals include generic versions of Xarelto (rivaroxaban) for blood clot prevention, Complera for HIV treatment, and Fycompa (perampanel) for seizure management.
  • These generic approvals span diverse therapeutic areas from oncology to ophthalmology, potentially reducing healthcare costs while maintaining equivalent clinical benefits to brand-name products.

FDA Approves Theratechnologies' EGRIFTA SV Prior Approval Supplement and Alpha Tau's Trial for Recurrent Glioblastoma

FDA ApprovalOncology
  • Theratechnologies has received FDA approval for a Prior Approval Supplement (PAS) for EGRIFTA SV, paving the way for its replacement with the new EGRIFTA WR formulation while ensuring continued distribution of EGRIFTA SV.
  • Alpha Tau has secured FDA approval to initiate a clinical trial evaluating its Alpha DaRT technology for patients with recurrent glioblastoma, representing a potential new treatment approach for this aggressive brain cancer.
  • Both regulatory milestones highlight ongoing innovation in specialized therapeutic areas, with Theratechnologies focusing on metabolic conditions and Alpha Tau advancing novel radiation technology for difficult-to-treat cancers.

Edgewise Therapeutics Faces Regulatory and Safety Setbacks Across Multiple Drug Programs

FDA Approval
  • Edgewise Therapeutics received an FDA determination that mid-stage study data for its muscular dystrophy drug was insufficient for accelerated approval, though the agency validated the physical ability endpoint for traditional approval.
  • The company disclosed safety concerns in a separate heart disease trial for EDG-7500, including two cases of dangerous atrial fibrillation that prompted analyst downgrades.
  • Scotiabank downgraded the stock from Sector Outperform to Sector Perform, cutting the price target from $50 to $14, citing safety issues that undermine the drug's competitive positioning.
  • Despite setbacks, J.P.Morgan analysts remain positive on the company's cardiovascular assets as the primary value driver in the mid-term.

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