[{"orgOrder":0,"company":"Nevakar","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Nevakar Announces FDA Approval for Ephedrine Sulfate Injection as Ready-To-Use Vials","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Nevakar","sponsor":"Nevakar","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zhaoke Ophthalmology Announced First Patient Completes Three Year Enrollment in Phase III CHAMP Study of NVK-002","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Nevakar","sponsor":"Laboratoires Thea","pharmaFlowCategory":"D","amount":"$135.0 million","upfrontCash":"Undisclosed","newsHeadline":"Nevakar and Th\u00e9a Enter into Licensing Agreement for the Commercialization of NVK-002 in Europe","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Nevakar","sponsor":"Oxford Finance LLC","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Nevakar Announces Closing Of $12 Million Convertible Note and Extension of Interest- Only Period with Oxford Finance","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Nevakar","sponsor":"Endo International","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Nevakar Injectables Announces the Launch of Ready-to-Use Ephedrine Injection Vials","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Nevakar","sponsor":"Par Pharmaceutical","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Nevakar Injectables Receives U.S. FDA Approval of Ready-to-Use Ephedrine Injection in a Prefilled Syringe","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Nevakar","sponsor":"Endo International","pharmaFlowCategory":"D","amount":"$35.0 million","upfrontCash":"Undisclosed","newsHeadline":"Endo Acquires Six Development-Stage, Ready-to-Use Injectable Product Candidates From Nevakar","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase II"},{"orgOrder":0,"company":"Nevakar","sponsor":"Vyluma","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Vyluma Completes Last Patient Visit for Primary Analysis of Pivotal Phase III CHAMP Study Evaluating NVK002 for the Treatment of Myopia Progression in Children","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Nevakar","sponsor":"Long Grove Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Long Grove Pharmaceuticals Secures Commercial Rights to an Essential Critical Care Medication","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Nevakar","sponsor":"Vyluma","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Vyluma Announces FDA Acceptance of New Drug Application for NVK002, Its Novel Investigational Treatment for Pediatric Myopia","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Nevakar Injectables","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Nevakar Injectables Announces FDA Approval of Cyclophosphamide RTD Solution","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals by Nevakar
FDA has approved its new drug application for Cyclophosphamide Injection, 200mg/mL vials for use in combination therapy for various types of cancers, including malignant lymphoma, multiple myeloma, and various types of leukemia.
NVK002 (atropine) is an investigational, preservative-free, low-dose atropine eye drop, using Vyluma’s proprietary technology to address stability, tolerability, and safety and developed for the treatment of Pediatric Myopia.
Under the agreement, Long Grove Pharmaceuticals in-licensed Norepinephrine Bitartrate in 0.9% Sodium Chloride premix formulation, indicated to raise blood pressure in adult patients with severe, acute hypotension, from Nevakar Injectables.
NVK002 (atropine) is a proprietary, investigational, preservative-free eye drop administered nightly, which, if approved, would be the first-in-class pharmaceutical treatment for myopia progression in children.
With the acquisition, Endo controls all remaining development, approval, launch and commercialization activities for the product candidates, NVK009 (Gabapentin). Endo's Par Sterile Products business will commercialize the products in the United States.
Ephedrine Sulfate Injection (“Ephedrine”) in a prefilled syringe is a widely used injectable vasopressor agent indicated for the treatment of clinically important hypotension occurring during surgery.
Ephedrine is a widely used injectable vasopressor agent indicated for the treatment of clinically important hypotension occurring during surgery, Ephedrine sulfate injection, a formulation pre-diluted to a 5mg/mL concentration and supplied in a 10mL vial.
The financing will support the Phase III clinical study for NVK002, Vyluma’s first-in-class pharmaceutical treatment for slowing the progression of myopia in children.
Under the terms of the agreement, Nevakar will develop and obtain European Medicines Agency (“EMA”) approval for NVK-002, and Théa will launch, distribute, and support the product in Europe, as well as in parts of North Africa.
The CHAMP Study is an FDA drug trial that evaluates the ability of its lead compound, NVK-002, to slow the progression of myopia in children. NVK-002 is a proprietary, investigational, preservative-free eye drop administered nightly and intended for patients ages 3 to 17.