Tetracycline Hydrochloride

DUBLIN, Dec. 14, 2023 /PRNewswire/ -- The "Ranibizumab (Lucentis) Biosimilars Pipeline Review" report has been added to ResearchAndMarkets.com's offering. This product provides basic information on approved drugs and drug candidates in research and development as biosimilar antibodies of Lucentis (ranibizumab). Lucentis (ranibizumab injection) is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment (Fab) designed for intraocular use. Ranibizumab binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A). Ranibizumab, which lacks an Fc region, has a molecular weight of approximately 48 kilodaltons and is produced by an E. coli expression system in a nutrient medium containing the antibiotic tetracycline. Tetracycline is not detectable in the final product. Lucentis is FDA-approved for the treatment of patients with wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) and myopic choroidal neovascularization (mCNV). Lucentis was developed by Genentech, a member of the Roche Group. The company retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world. Outside the United States, Lucentis is approved in more than 120 countries to treat adult patients with wet AMD, for the treatment of visual impairment due to DME, due to macular edema secondary to both branch retinal vein occlusion (BRVO), central retinal vein occlusion (CRVO) and due to choroidal neovascularization (CNV). Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. The first Lucentis biosimilar products have been launched in the US, Europe, Japan and other territories. This product consists of: Competitors described in a tabular format covering drug code/INN, target(s)/MoA, class of compound, territory of main competitor, indication(s) & R&D stage. Project History with link to source of information (press release, homepage, abstracts, presentations, annual reports etc). One-month online access to the publisher's database For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

SILVER SPRING, Md., Dec. 14, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is announcing the issuance of nine warning letters to manufacturers and distributors of unapproved and misbranded antimicrobial animal drugs for violations of federal law. The agency is concerned because these products contain antimicrobials that are important in human medicine and using them without medical oversight contributes to the development of antimicrobial resistance. Antimicrobial resistance happens when microorganisms like bacteria become resistant to the antimicrobials that are designed to kill them. The marketed products are not the subject of a New Animal Drug Application, nor are they Conditionally Approved or on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species – the main legal pathways for animal drugs to reach the marketplace. Therefore, the FDA has not verified their safety or effectiveness as part of the animal drug review process or facility inspections. The animal products referenced in the warning letters are marketed and labeled for minor species such as aquarium fish and pet birds. They contain antimicrobials that are important in human medicine, such as amoxicillin, penicillin, tetracycline, and erythromycin, and are being illegally marketed over the counter. "These unapproved animal drugs pose a two-fold risk to public health," said Tracey Forfa, J.D., director of the FDA's Center for Veterinary Medicine. "First, these products haven't been through the FDA drug review process, and we don't know whether they're safe or effective, or even contain what the label states. Second, inappropriate use of medically important antimicrobials contributes to the development of antimicrobial resistance, which affects both human and animal health." All approved animal drugs containing these antimicrobials are only legally available by prescription from a licensed veterinarian. Veterinarians use their specialized training and experience to properly diagnose and treat animal health issues. Providing animals with the appropriate drug is more likely to effectively resolve infections and reduce the need for extended treatment with antimicrobials. Judicious use of antimicrobials reduces the risk of developing antimicrobial resistance and helps ensure better health outcomes. Additionally, it's important to note that using unapproved animal drugs in humans can be especially dangerous because these products have not been evaluated by the FDA, and because many animal drugs are not identical to similar products approved for use in people. Self-diagnosis and treatment with unapproved animal antimicrobials could delay effective treatment, allowing infections to become more severe and/or more resistant to antimicrobials. Anyone currently using or administering the products included in these warning letters should safely dispose of them. Animal owners or caretakers should consult a licensed veterinarian, and people should consult a licensed health care provider, to obtain an accurate diagnosis and appropriate treatment. Consumers, veterinarians, and health care providers are encouraged to report human and animal adverse events associated with these products to the FDA's Center for Veterinary Medicine: How to Report Animal Drug and Device Side Effects and Product Problems. The following companies received warning letters: American Aquarium Products Aquanest Biotic Aquarium Pharmacy LLC California Veterinary Supply Chewy Inc. Kraft Drug Midland Veterinary Services LLC Silver Lease LLC Valley Veterinary Clinic LTD The FDA has asked the companies to respond to the warning letters within 15 days of receipt to state how they will address the violations cited in the warning letters. Failure to address the violations promptly may result in the FDA's legal action, including product seizure and/or a court order requiring a company to stop manufacturing and distributing unapproved products. The FDA will continue to monitor the marketplace and take necessary steps to protect human and animal health against companies selling unapproved animal drugs that can put people and animals at risk. Additional Information How to Report Animal Drug and Device Side Effects and Product Problems FDA's Concerns About Unapproved Animal Drugs Ornamental Fish Drugs and You CVM: Antimicrobial Resistance Media Contact: Veronika Pfaeffle , 301-310-2576 and Janell Goodwin, 240-393-3067 Consumer Inquiries: [email protected] or 888-INFO-FDA 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, radiation-emitting electronic products, and for regulating tobacco products. SOURCE U.S. Food and Drug Administration