ISHIHARA SANGYO KAISHA LTD.

SILVER SPRING, Md., Nov. 15, 2022 /PRNewswire/ -- Today, the U.S. Food and Drug Administration conditionally approved Panoquell-CA1 (fuzapladib sodium for injection) for the management of clinical signs associated with acute onset of pancreatitis in dogs. Panoquell-CA1 is an injectable drug intended for use while the dog is hospitalized for treatment of the disease. Pancreatitis is a painful inflammatory disease of the pancreas that can be life-threatening and generally requires that dogs be hospitalized for treatment. In most cases, it occurs spontaneously. Common factors that increase the chance of developing pancreatitis include when dogs eat something outside of their normal diet (particularly fatty foods), treatment with certain medications, and diseases like diabetes mellitus. It is more common in certain breeds of dogs and in some dogs may become a recurring or chronic condition. "This is the first drug to address a serious and life-threatening disease that previously could only be managed through supportive care, such as intravenous fluids, pain medication, anti-emetics, and dietary rest," said Steven M. Solomon, D.V.M., M.P.H., director of the FDA's Center for Veterinary Medicine. "The conditional approval pathway allows medications like Panoquell-CA1 to reach the marketplace more quickly, and in this case gives dogs suffering from acute onset of pancreatitis earlier access to a drug to manage this disease." Conditional approval also means that, when used according to the label, the drug is safe and has a reasonable expectation of effectiveness. Veterinarian access to critical animal drugs provides more options for treating animals with uncommon conditions, serious or life-threatening diseases, or diseases without existing or adequate therapies. The initial conditional approval is valid for one year with the potential for four annual renewals. During this time, the animal drug sponsor must demonstrate active progress toward proving substantial evidence of effectiveness for full approval. If the sponsor does not meet the requirements for substantial evidence of effectiveness at the conclusion of five years, the product can no longer be marketed. Fuzapladib sodium, the active ingredient in Panoquell, has been approved since 2018 in Japan to improve clinical signs in the acute phase of pancreatitis in dogs, but not in the United States until today. The FDA reviewed data associated with fuzapladib's use in Japan as part of its assessment of the application for conditional approval. Veterinarians should advise owners about the possible side effects, which include loss of appetite, digestive tract disorders, respiratory tract disorders, liver disease and jaundice, before using the drug. The FDA encourages dog owners to work with their veterinarian to report any adverse events or side effects potentially related to the use of any drug, including Panoquell-CA1. The FDA granted conditional approval of Panoquell-CA1 to Ishihara Sangyo Kaisha Ltd. Additional Information: Panoquell-CA1 Freedom of Information Summary Conditional Approval Explained: A Resource for Veterinarians Minor Use/Minor Species Media Contact: Veronika Pfaeffle, 310-301-2576 Veterinary and Consumer Inquiries: [email protected], 800-835-4709 The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. SOURCE U.S. Food and Drug Administration

Dublin, Aug. 27, 2021 (GLOBE NEWSWIRE) -- The "Titanium Additives Market Research Report by Application, by Region - Global Forecast to 2026 - Cumulative Impact of COVID-19" report has been added to ResearchAndMarkets.com's offering. The Global Titanium Additives Market size was estimated at USD 691.75 Million in 2020 and expected to reach USD 744.94 Million in 2021, at a Compound Annual Growth Rate (CAGR) 8.02% to reach USD 1,099.36 Million by 2026.Market Statistics: The report provides market sizing and forecast across five major currencies - USD, EUR GBP, JPY, and AUD. It helps organization leaders make better decisions when currency exchange data is readily available. In this report, the years 2018 and 2019 are considered historical years, 2020 as the base year, 2021 as the estimated year, and years from 2022 to 2026 are considered the forecast period.Market Segmentation & Coverage: This research report categorizes the Titanium Additives to forecast the revenues and analyze the trends in each of the following sub-markets: Competitive Strategic Window: The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies to help the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. It describes the optimal or favorable fit for the vendors to adopt successive merger and acquisition strategies, geography expansion, research & development, and new product introduction strategies to execute further business expansion and growth during a forecast period.FPNV Positioning Matrix: The FPNV Positioning Matrix evaluates and categorizes the vendors in the Titanium Additives Market based on Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) that aids businesses in better decision making and understanding the competitive landscape.Market Share Analysis: The Market Share Analysis offers the analysis of vendors considering their contribution to the overall market. It provides the idea of its revenue generation into the overall market compared to other vendors in the space. It provides insights into how vendors are performing in terms of revenue generation and customer base compared to others. Knowing market share offers an idea of the size and competitiveness of the vendors for the base year. It reveals the market characteristics in terms of accumulation, fragmentation, dominance, and amalgamation traits.Company Usability Profiles: The report profoundly explores the recent significant developments by the leading vendors and innovation profiles in the Global Titanium Additives Market, including Argex Titanium Inc., Arya Chem Inc., Chemours Company, CRS Holdings Inc., DuPont de Nemours, Inc., Evonik Industries AG, Farinia Group, General Electric Company, GKN Hoeganaes, GKN Sinter Metals Engineering GmbH, Honeywell International Inc, INEOS AG, Ishihara Sangyo Kaisha Ltd., Kish Company, Inc., NL Industries, Inc, Praxair International, Inc., Shandong Doguide Group Co., Ltd, SLM Solutions Group AG, SpecialChem, Tayca Corporation, Titomic Limited, Tronox Limited, UL LLC, and Venator Materials PLC.The report provides insights on the following pointers:1. Market Penetration: Provides comprehensive information on the market offered by the key players2. Market Development: Provides in-depth information about lucrative emerging markets and analyze penetration across mature segments of the markets3. Market Diversification: Provides detailed information about new product launches, untapped geographies, recent developments, and investments4. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, certification, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players5. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and breakthrough product developmentsThe report answers questions such as:1. What is the market size and forecast of the Global Titanium Additives Market?2. What are the inhibiting factors and impact of COVID-19 shaping the Global Titanium Additives Market during the forecast period?3. Which are the products/segments/applications/areas to invest in over the forecast period in the Global Titanium Additives Market?4. What is the competitive strategic window for opportunities in the Global Titanium Additives Market?5. What are the technology trends and regulatory frameworks in the Global Titanium Additives Market?6. What is the market share of the leading vendors in the Global Titanium Additives Market?7. What modes and strategic moves are considered suitable for entering the Global Titanium Additives Market?Key Topics Covered: 1. Preface 2. Research Methodology 3. Executive Summary 4. Market Overview4.1. Introduction4.2. Cumulative Impact of COVID-195. Market Insights5.1. Market Dynamics5.1.1. Drivers5.1.1.1. Use of titanium additives in aerospace and medical markets5.1.1.2. Growing paints and coatings industry5.1.1.3. Rising automotive production and expenditure in the construction sector5.1.1.4. Increasing demand for titanium additives for the coloring applications of food items, paper and pulp, textiles, and cosmetics5.1.2. Restraints5.1.2.1. Stringent government regulations5.1.3. Opportunities5.1.3.1. Technological innovations aimed at improving manufacturing processes5.1.3.2. Ongoing trend of using self-cleaning technologies across various industries5.1.4. Challenges5.1.4.1. Fluctuation in prices owing to a large variation in supply and demand5.2. Porters Five Forces Analysis5.2.1. Threat of New Entrants5.2.2. Threat of Substitutes5.2.3. Bargaining Power of Customers5.2.4. Bargaining Power of Suppliers5.2.5. Industry Rivalry6. Titanium Additives Market, by Application6.1. Introduction6.2. Aerospace industry6.3. Automotive Industry6.4. Engine Oil6.5. Food Industry6.6. Healthcare & Pharmaceutical6.7. Industrial Engineering7. Titanium Additives Market, by Process7.1. Introduction7.2. Direct Metal Deposition (DED)7.3. Direct Metal Laser Sintering (DMLS)7.4. Electron Beam Melting (EBM)7.5. Laser Metal Deposition (LMD)7.6. Metal Injection Molding (MIM)7.7. Selective Laser Melting (SLM)8. Americas Titanium Additives Market8.1. Introduction8.2. Argentina8.3. Brazil8.4. Canada8.5. Mexico8.6. United States9. Asia-Pacific Titanium Additives Market9.1. Introduction9.2. Australia9.3. China9.4. India9.5. Indonesia9.6. Japan9.7. Malaysia9.8. Philippines9.9. Singapore9.10. South Korea9.11. Thailand10. Europe, Middle East & Africa Titanium Additives Market10.1. Introduction10.2. France10.3. Germany10.4. Italy10.5. Netherlands10.6. Qatar10.7. Russia10.8. Saudi Arabia10.9. South Africa10.10. Spain10.11. United Arab Emirates10.12. United Kingdom11. Competitive Landscape11.1. FPNV Positioning Matrix11.1.1. Quadrants11.1.2. Business Strategy11.1.3. Product Satisfaction11.2. Market Ranking Analysis11.3. Market Share Analysis, By Key Player11.4. Competitive Scenario11.4.1. Merger & Acquisition11.4.2. Agreement, Collaboration, & Partnership11.4.3. New Product Launch & Enhancement11.4.4. Investment & Funding11.4.5. Award, Recognition, & Expansion12. Company Usability Profiles12.1. Argex Titanium Inc.12.2. Arya Chem Inc.12.3. Chemours Company12.4. CRS Holdings Inc.12.5. DuPont de Nemours, Inc.12.6. Evonik Industries AG12.7. Farinia Group12.8. General Electric Company12.9. GKN Hoeganaes12.10. GKN Sinter Metals Engineering GmbH12.11. Honeywell International Inc12.12. INEOS AG12.13. Ishihara Sangyo Kaisha Ltd.12.14. Kish Company, Inc.12.15. NL Industries, Inc12.16. Praxair International, Inc.12.17. Shandong Doguide Group Co., Ltd12.18. SLM Solutions Group AG12.19. SpecialChem12.20. Tayca Corporation12.21. Titomic Limited12.22. Tronox Limited12.23. UL LLC12.24. Venator Materials PLC13. Appendix For more information about this report visit