Thursday, September 14, 2023
FDA Conditionally Approves Phenobarbital Tablets to Control Seizures in Dogs with Idiopathic Epilepsy
Today, the U.S. Food and Drug Administration conditionally approved Fidoquel-CA1 (phenobarbital tablets) for the control of seizures associated with idiopathic epilepsy in dogs. Idiopathic epilepsy is a type of seizure disorder without a known cause and is a serious or life-threatening condition that affects approximately 5% of dogs.
Agency Warns Eight Companies Regarding Their Unapproved Ophthalmic Drugs
The U.S. Food and Drug Administration has issued warning letters to eight companies for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law. These warning letters are part of the agency’s ongoing effort to protect Americans from potentially harmful ophthalmic products.
Eye products addressed in the eight warning letters are illegally marketed to treat conditions such as conjunctivitis (“pink eye”), cataracts, glaucoma and others. Some of the FDA warning letters also cite the companies involved for quality issues related to product sterility.
The FDA is particularly concerned that these illegally marketed, unapproved ophthalmic drug products pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. Some of these eye products are labeled to contain silver, which may be characterized as silver sulfate, silver sulphate or argentum. Long-term use of drugs containing silver can cause some areas of the skin and other body tissues, including in the eye, to permanently turn gray or blue-gray, which is called “argyria.” Additionally, unapproved drugs that claim to cure, treat or prevent serious conditions may cause consumers to delay or stop medical treatments that have been found safe and effective through the FDA review process.
“The FDA is committed to ensuring the medicines Americans take are safe, effective and of high quality. When we identify illegally marketed, unapproved drugs and lapses in drug quality that pose potential risks, the FDA works to notify the companies involved of the violations,” said Jill Furman, director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research. “We will continue to investigate potentially harmful eye products and work to ensure violative products stay off store shelves so that consumers can continue taking the medicines they need without concern.”
The agency issued warning letters to the following companies:
- Boiron Inc.
- CVS Health
- DR Vitamin Solutions
- Natural Ophthalmics, Inc.
- OcluMed LLC
- Similasan AG/Similasan USA
- TRP Company, Inc.
- Walgreens Boots Alliance, Inc.
Consumers currently using eye products included in these warning letters should speak to their health care professional. The FDA encourages consumers and health care professionals to report any adverse reaction to the agency’s MedWatch program.
The FDA has asked the companies to respond within 15 days of receipt of the letters, stating how they will correct the violations. Failure to correct the violations promptly may result in the FDA pursuing legal action, including product seizure and/or a court order requiring a company to stop manufacturing and distributing an unapproved product. Additionally, the agency has placed some of these companies on import alert to help stop their products from entering the U.S. and reaching consumers.
The FDA’s investigation of eye products is ongoing, and the agency may take additional regulatory or enforcement actions, as warranted.
|Safecor Health, LLC||Division of Pharmaceutical Quality Operations I||CGMP/Finished Pharmaceuticals/Adulterated|
|RickinmortyBars||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|Vape Society Supply||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|Del Valle Import & Export 3, Inc. DBA El Progreso Imports||Division of West Coast Imports||Foreign Supplier Verification Program (FSVP)|
|Natural Ophthalmics, Inc.||Center for Drug Evaluation and Research | CDER||Unapproved New Drugs/Misbranded|
|Boiron, Inc.||Center for Drug Evaluation and Research | CDER||Unapproved New Drugs/Misbranded|
|Similasan AG||Center for Drug Evaluation and Research | CDER||CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug|
|TRP Company, Inc||Center for Drug Evaluation and Research | CDER||Unapproved New Drugs/Misbranded|
|Walgreens Boots Alliance, Inc.||Center for Drug Evaluation and Research | CDER||Unapproved New Drugs/Misbranded|
|CVS Health||Center for Drug Evaluation and Research | CDER||Unapproved New Drugs/Misbranded|
FDA Seeks Public Comment on Guidance Related to Informed Consent for Companion Animal Studies
Today, the U.S. Food and Drug Administration is announcing the availability of draft guidance for industry that will help ensure that animal owners who are considering having their pet participate in a clinical study for a new animal drug understand the risks and benefits of their participation. Draft Guidance for Industry (GFI) #282, entitled “Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals,” outlines the basic elements of informed consent in animal drug clinical studies.
Informed consent is a documented process by which an animal’s owner – or someone acting on behalf of the owner – voluntarily confirms the owner’s willingness to allow their animal(s) to participate in a particular study, after having been informed of all aspects of the study that may be relevant to the owner’s decision to participate. An animal drug sponsor or investigator (the individual responsible for all aspects of the conduct of the study at their study site) should ensure that the owner is provided with adequate information and time to allow for an informed decision about whether they want to voluntarily participate in a clinical investigation.