FDA still going after unapproved drugs
The FDA says it is continuing its battle against unapproved drugs with a consent decree signed with one manufacturer of unapproved drugs and Warning Letters sent to four others.
The actions are consistent, the agency said, with a guidance document it issued in June, Marketed Unapproved Drugs— Compliance Policy Guide, that says firms marketing drugs requiring FDA approval must submit applications showing their products are safe and effective before marketing them.
The latest consent decree is with Syntho Pharmaceuticals, and Intermax Pharmaceuticals, both of Farmingdale, NY, and their owners. The decree includes a permanent injunction barring the companies from manufacturing, processing, packing, labeling, and distributing cold-cough medications: Coldec tablets, Coldec D tablets, Coldec TR tablets, Dyphylline & Guaifensin tablets and Usept tablets, an antiseptic for urinary tract infections, and any other drugs that do not have FDA approval.
Meanwhile, outgoing Senate Finance Committee chairman Chuck Grassley (R-IA) has asked the FDA what steps it will take to inform providers, pharmacists and the public that not all prescription drugs are FDA-approved.