Ciprofloxacin

Delivery Method: VIA EMAIL WITH READ RECEIPT Product: Animal & Veterinary Drugs Recipient: Recipient Name Cameron Muir FishMoxFishFlex/Simple Pet Health LLC 520 South 850 East, Ste A1 Lehi , UT 84043 United States info@fishmoxfishflex.com Issuing Office: Center for Veterinary Medicine United States WARNING LETTER May 8, 2025 Re: 707196 Dear Cameron Muir: This letter concerns your firm's distribution of animal drug products for use in aquarium fish and birds. In April 2025, the U.S. Food and Drug Administration (FDA) reviewed your website (https://fishmoxfishflex.com/), where you take orders for Fish Mox and Fish Mox Forte Amoxicillin, Bird Zithro Azithromycin, Fish Flex Cephalexin and Fish Flex Forte Cephalexin, Fish Flox Forte Ciprofloxacin, Fish Cin Clindamycin, Fish Doxy Doxycycline, Fish Zole Metronidazole and Fish Zole Forte Metronidazole, Fish Pen Forte Penicillin, and Fish Sulfa Forte Sulfamethoxazole /Trimethoprim. The claims on your website establish that these products are intended for use in the cure, mitigation, treatment, or prevention of diseases in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)]. In addition, these animal drugs are misbranded under section 502(o) of the FD&C Act [21 U.S.C. § 352(o)] because they have not been drug listed with FDA, nor have they been manufactured in a facility that is registered with FDA in accordance with sections 510(b) and (j) of the FD&C Act [21 U.S.C. § 360(b), (j)]. As discussed below, introducing or delivering these unapproved and misbranded new animal drugs for introduction into interstate commerce violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. UNAPPROVED NEW ANIMAL DRUGS Examples of claims observed on your website (https://fishmoxfishflex.com/) that establish the intended use of these products as drugs include, but may not be limited to, the following: Fish • Simple Pet Health Fish Mox and Simple Pet Health Fish Mox Forte (Amoxicillin), 250 mg and 500 mg capsules. According to your website an “Antibacterial Fish Medication,” this product “is a broad-spectrum antibiotic that controls gram-positive and some gram-negative bacteria in fish. It works by halting the multiplication of bacteria associated with both fresh and salt water ornamental fish diseases. This fish antibiotic is useful for control of some common bacterial diseases in fish including Dropsy, Fin Rot, Red Pest, and disease caused by bacteria such as Aeromonas, Pseudomonas, and Mycobacterial (Gill diseases and Chondrococcus).” • Simple Pet Health Fish Flex and Simple Pet Health Fish Flex Forte (Cephalexin), 250 mg and 500 mg capsules. According to your website an “Antibacterial Fish Medication,” this product “is a broad-spectrum antibiotic that is used in treating a wide variety of non-specific bacterial infections during the most active and multiplying stages of infection. This effective fish antibiotic is helpful with treating a number of pathogenic bacteria associated with ornamental fish diseases.” • Simple Pet Health Fish Flox Forte (Ciprofloxacin), 500 mg tablets. According to your website an “Antibacterial Fish Medication,” “You can help your finned friends feel better and watch your aquarium thrive again with Ciprofloxacin Tablets. This synthetic, board spectrum medication is used treat different strains of bacteria that can plague your fish.” • Simple Pet Health Fish Cin (Clindamycin), 150 mg tablets. According to your website an “Antibacterial Fish Medication,” this product “is an antibiotic that exerts a bactericidal action on gram-positive and some gram-negative bacteria in fish. Used for the control of some common bacterial fish diseases, such as Aeromonas, Pseudomonas, and Mycobacterial (Gill diseases and Chondrococcus).” • Simple Pet Health Fish Doxy (Doxycycline Hyclate), 100 mg capsules. According to your website an “Antibacterial Fish Medication,” this product “is an antibiotic that exerts a bactericidal action on gram-positive and some gram-negative bacteria in fish. Used for the control of some common bacterial fish diseases such as Tail Rot, Mouth Rot, Fin Rot, and Septicemia.” • Simple Pet Health Fish Zole and Simple Pet Health Fish Zole Forte (Metronidazole), 250 mg and 500 mg tablets. According to your website an “Antibacterial Fish Medication,” this product “is an antibiotic that exerts a bactericidal action on gram-positive and some gram-negative bacteria in fish. Useful to help control some common bacterial diseases in fish such as Aeromonas, Pseudomonas, and Mycobacterial (Gill diseases and Chondrococcus). Effective against anaerobic bacteria, a bacteria that only grows where there is no oxygen. Also used to control parasitic diseases such as Cryptocaryon irritans, Ichthyophthirius multifiliis, and Hexamita.” • Simple Pet Health Fish Pen Forte (Penicillin), 500 mg tablets. According to your website an “Antibacterial Fish Medication,” this product “is an antibiotic that exerts a bactericidal action on gram-positive and some gram-negative bacteria in fish. Used in the control of some common bacterial diseases in fish, including diseases caused by bacteria such as fin and tail rot and Flexibacteria infections.” • Simple Pet Health Fish Sulfa Forte (Sulfamethoxazole/Trimethoprim), 800/160 mg tablets. According to your website an “Antibacterial Fish Medication,” this product “is an antibiotic that exerts a bactericidal action on gram-positive and some gram-negative bacteria in fish. Used in the control of some common bacterial diseases in fish, such as Aeromonas, Pseudomonas, and Mycobacterial (Gill diseases and Chondrococcus).” Birds • Simple Pet Health Bird Zithro (Azithromycin), 250 mg tablets. According to your website an “Antibacterial Bird Medication,” this product “is a fish antibiotic that is used for systemic and local infections in pigeons, pet birds, and exotic birds. This antibiotic is effective against gram-positive bacteria, as well as some gram-negative bacteria, spirochetes, anaerobic bacteria, and other types of microorganisms. Bird ZithroTM is also effective against Chlamydia psittaci in cockatiels. The active ingredient in this medication works by inhibiting the growth of bacteria, which helps to eliminate the bacteria and the infection.” These products are new animal drugs under section 201(v) of the FD&C Act [21 U.S.C. § 321(v)] because they are for use in nonfood-producing fish and birds, which are minor species as defined by sections 201(nn) and (oo) of the FD&C Act [21 U.S.C. § 321(nn) and (oo)], and are not the subject of a final FDA regulation finding either that the drugs are generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the drug’s labeling, or finding that the exception to the criterion in section 201(v)(1) of the FD&C Act has been met. To be legally marketed, a new animal drug must be the subject of an approved new animal drug application, a conditionally approved new animal drug application, or a listing on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (“index listing”) under section 512, 571, or 572 of the FD&C Act [21 U.S.C. § 360b, 360ccc, and 360ccc-1]. The FDA approval and index listing processes allow FDA to ensure that there is adequate evidence to demonstrate that new animal drugs are safe, properly manufactured, accurately labeled, and meet the relevant effectiveness standard. The animal drugs named above have not been approved, conditionally approved, or index listed. Animal drugs that lack the required approval or index listing are considered unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act [21 U.S.C. §§ 360b(a) and 351(a)(5)]. Introduction or delivery for introduction of an adulterated animal drug into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. The FDA is particularly concerned about the marketing of these unapproved animal drugs because they contain antimicrobials considered medically important to human health. The growing threat of antimicrobial resistance, especially to drugs that are medically important in human medicine, has prompted FDA to promote judicious use of these drugs in animals. A key part of this effort is ensuring that these medically important antimicrobials are used only under the supervision of a licensed veterinarian. Over-the-counter use of these drugs without veterinary oversight contributes to the development of antimicrobial resistance, posing risks to both human and animal health. MISBRANDED NEW ANIMAL DRUGS Sections 510(b)(1) and (j)(1) of the FD&C Act [21 U.S.C. § 360(b), (j)] require that manufacturers (which includes repackers and relabelers) of drugs, including animal drugs, register their manufacturing establishments with FDA and provide the agency with a list of all the drug products they manufacture. Drugs that are manufactured in unregistered establishments or that have not been listed with FDA are misbranded under section 502(o) of the FD&C Act. None of the animal drugs in this letter are drug listed with FDA, nor have they been manufactured in a facility that is registered with FDA. Accordingly, these animal drugs are misbranded. Introduction or delivery for introduction of a misbranded animal drug into interstate commerce is prohibited under section 301(a) of the FD&C Act. This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product(s). You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to legal or regulatory action, including without limitation, seizure and injunction. You should be aware that if we take enforcement action against any of the drugs named above or other unapproved/unindexed products you market that contain medically important antimicrobials, we may take action against all of your products that violate the FD&C Act at the same time, including but not limited to enjoining the manufacturing and distribution of all of your unapproved/unindexed products. We have the following comments: 1. You can legally market the products named above if you obtain an index listing, approval, or conditional approval. Information about the processes and requirements for obtaining an index listing and various types of animal drug approval is available on the FDA website at • https://www.fda.gov/animal-veterinary/development-approval-process/minor-useminor-species and • https://www.fda.gov/animal-veterinary/development-approval-process/new-animal-drug-applications The index listing process was added to the FD&C Act in 2004 as a streamlined alternative process that addresses the challenges of obtaining FDA approval for drugs for minor species (which are any animal species other than horses, cattle, pigs, dogs, cats, chickens, and turkeys). Drugs intended for use in minor species not used for human or animal food are eligible for index listing. Because the above-named products are intended for use in nonfood-producing fish and birds, you may wish to explore the index listing process. The approval process can also be used for drugs for use in these species. 2. Information on establishment registration and drug listing is available on the FDA website at: • https://www.fda.gov/industry/fda-basics-industry/registration-and-listing Within fifteen (15) working days of receiving this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. Your written response should be sent to Dr. Vic Boddie, United States Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance, by emailing CVMUnapprovedDrugs@fda.hhs.gov. Sincerely, /S/ Cindy L. Burnsteel, DVM Acting Director, Division of Drug Compliance Office of Surveillance and Compliance Center for Veterinary Medicine Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 2b study completed in amyotrophic lateral sclerosis (ALS) demonstrated lead asset PrimeC slows disease progression and functional decline Ongoing partnership discussions to advance PrimeC to Phase 3 study in ALS and commercialization Phase 3 study design for PrimeC in ALS aligned with FDA; planned initiation in 2025 CAMBRIDGE, Mass., April 7, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a clinical-stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today reports its financial results for the year ended December 31, 2024 and provides a business update. Business highlights from 2024 and to date PrimeC achieved primary and secondary clinical endpoints in PARADIGM Phase 2b study investigating PrimeC in ALS (n=68) with data showing the following: - PrimeC slowed disease progression (measured by ALSFRS-R) by approximately 33% after 18 months (p=0.007) - PrimeC reduced likelihood of mortality, hospitalization and respiratory support, resulting in an overall 58% improvement in survival rates. - PrimeC slowed functional decline, especially speaking and swallowing functions. - PrimeC demonstrated favorable safety and tolerability profile, achieving the study's primary endpoint. Phase 3 study design for PrimeC for ALS aligned with FDA following Type C meeting. Partnership discussions are continuing in order to advance PrimeC towards regulatory approval and eventual commercialization. Plans to file for early commercialization for PrimeC in Canada, with an estimated potential market opportunity of $100m-$150m in peak annual revenues. Key patent granted by U.S. Patent and Trademark Office (USPTO), extending the patent protection for the novel formulation of PrimeC until 2042. "2024 was a year of significant clinical progress for NeuroSense," stated NeuroSense CEO, Alon Ben-Noon. "We successfully completed our Phase 2b study for PrimeC in ALS, with data showing transformative results in a neurodegenerative indication of immense medical need. The results conclude with PrimeC's disease-modifying potential and strongly support advancing PrimeC towards a Phase 3 study. With positive FDA feedback on the proposed study design, we are putting everything in place for the next stage of NeuroSense's growth, driven by PrimeC's continued clinical development." Financial Results Research and development expenses for the years ended December 31, 2024 and 2023 were $5.7 million and $7.3 million, respectively. The decrease of $1.6, or 21.9%, was mainly attributed to a decrease in our expenses to subcontractors and consultants and a decrease in share-based payment expense. General and administrative expenses for the years ended December 31, 2024 and 2023 were $4.2 million and $4.8 million, respectively. The decrease of $0.6, or 12.5%, was mainly attributed to a decrease in share-based compensation and insurance costs and a decrease in salaries and social benefit expenses mainly due to decrease in the number of employees which were offset by an increase in professional services expenses. As of December 31, 2024, NeuroSense had cash of approximately $3.4 million. A summary of NeuroSense's consolidated financial results is included in the tables below. A copy of the Company's annual report on Form 20-F for the year ended December 31, 2024 has been filed with the U.S. Securities and Exchange Commission at and posted on the Company's investor relations website at . The Company will deliver a hard copy of its annual report, including its complete audited financial statements, free of charge, to its shareholders upon request at [email protected]. About ALS Amyotrophic lateral sclerosis ("ALS") is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU. About PrimeC PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ("RNA") regulation to potentially inhibit the progression of ALS. NeuroSense completed a Phase 2a clinical trial which met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC's biological activity. PrimeC was granted Orphan Drug Designation by the U.S. Food and Drug Administration and the European Medicines Agency. About NeuroSense NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases. For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels. Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics' current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding ongoing partnership discussions, the timing of initiation of studies, regulatory filings, meetings and regulatory decisions, market potential and expected growth in the market. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the risk that the partnership discussions will not lead to execution of a definitive agreement, or that, if executed, will not lead to the current anticipated benefits to NeuroSense, a delay in the planned Phase 3 study for PrimeC in ALS, lower than anticipated market opportunity in Canada and elsewhere, that regulatory approvals for PrimeC will be delayed or not obtained in Canada or elsewhere; unexpected R&D costs or operating expenses, insufficient capital to complete development of PrimeC, a delay in the development of PrimeC, the timing of expected regulatory and business milestones, risks associated with meeting with the FDA and Health Canada to determine the best path forward following the results from PARADIGM clinical trial, including a delay in any such meeting; the potential for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data; the development and commercial potential of any product candidates of Neurosense; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense's filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading "Risk Factors" in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 7, 2025 and NeuroSense's subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law. Logo - SOURCE NeuroSense WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED