Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Wednesday, January 11, 2023
PharmaCanna | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
Purecraft LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |||
Medical Mikes, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |||
San-Rey Produce Inc. | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | |||
Sun Pharmaceutical Industries Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | |||
Florida Gold Foods LLC | Division of Human and Animal Food Operations East IV | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||
Auto-Chlor System LLC | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated | |||
Aizu Olympus Co., Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded | |||
Olympus Medical Systems Corporation | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | |||
Distributor RFR, LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
pharmahealthonline.com | Center for Drug Evaluation and Research | CDER | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet |
FDA Approves First Generic Doramectin Topical Solution for Treatment of Certain Parasites in Cattle
Today the U.S. Food and Drug Administration approved DectoGard, the first generic doramectin topical solution for treatment and control of gastrointestinal roundworms, lungworms, eyeworms, grubs, biting and sucking lice, horn flies, and mange mites in cattle.
DectoGard is an antiparasitic drug that contains the same active ingredient (doramectin topical solution) in the same concentration and dosage form as the approved brand name drug product, Dectomax (doramectin topical solution), which was first approved for use in cattle on September 16, 1997. Additionally, data demonstrate that residues in food products derived from cattle treated with DectoGard will not represent a public health concern when the product is used according to the label.
Tuesday, January 10, 2023
Ropes & Gray LLP On January 5, 2023, the U.S. Federal Trade Commission ("FTC") published a sweeping proposed rule that, if finally issued, would prohibit… |
Gibbons PC On January 5, 2023, the Federal Trade Commission (FTC) announced a proposed rule (“Rule”) that would effectively impose a nationwide ban on all… |
Duane Morris LLP Just one day after entering into consent agreements invalidating non-competes with three companies, on January 5, 2023, the Federal Trade Commission… |