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U.S. Department of Health and Human Services

Combination Products

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Capsular Decisions - Products Assigned to CDER

A. Drugs

 

  • Ultrasound contrast agent
  • Dye mouthrinse to examine oral tissue  
  • Orally administered drug for ultrasound imaging
  • Drug used to determine plasma volume  
  • Inhaled chemoirritant to elicit cough reflex  
  • Hormone for the treatment of gastrointestinal disease
  • Vital dye for ophthalmic use  
  • Aerosolized polysaccharide for pulmonary disorder
  • Diagnostic drug administered to the bladder  
  • Drug for in vitro treatment of sperm  
  • Synthetic protein to treat HIV
  • Solution used in continuous renal replacement therapy procedures
  • Vitreous liquefaction agent
  • Oxygen-carrying liquid drug to treat pulmonary conditions
  • Antibiotic cream to treat nasal infections
  • Agent to decontaminate chemical and biological warfare agents
  • Extended-release synthetic compound for orthopedic use
  • Isotope-based drug combination to diagnose digestive disease
  • Topical agent for wound healing
  • Recombinant hormone for the treatment of obesity
  • Synthetic protein to treat chemotherapy side effect
  • Hydroxyapatite-based dentifrice
  • Solution for use in cardioplegia and preservation of the heart during cardiac surgery
  • Enzyme to degrade viscoelastic agent during cataract surgery
  • Synthetic immunomodulator for neurological use
  • Drug used in therapeutic ultrasound procedures
  • Polysaccharide for prevention/treatment of bacterial overgrowth
  • Heat-activated chemotherapy drug

 

B. Biological Products

 

  • Botulinum toxin for treatment of neuromuscular disorders
  • Recombinant protein for dental use
  • Monoclonal antibodies for treatment of blood disorder

 

C. Combination Products with Drug Primary Mode of Action

 

  • Cytotoxic agent and biological product for targeted cancer treatment
  • Gynecologic drug and delivery device  
  • Photosensitizing drug and light source for cancer treatment 
  • Drug and transdermal iontophoretic delivery system
  • Fluoride-containing dental device for anticaries treatment  
  • Fluoride varnish for anticaries treatment
  • Drug with injector to treat erectile dysfunction
  • Drug with injector to treat anaphylactic reactions
  • Drug with implantable delivery device  
  • Antiseptic skin preparation swabs  
  • Peritoneal dialysis solution and administration set 
  • Drug and delivery device for diagnosis of coronary artery disease
  • Drug and delivery system for cancer treatment  
  • Drug and radiation emitting device to treat cancer
  • Drug and delivery system for use with vein grafts
  • Antimicrobial barrier  
  • Spermicidal gel with delivery device
  • Antibiotic with biodegradable delivery device  
  • Drug reconstitution and delivery system
  • Contrast agent and saline flush syringes
  • Chemoablation drug and delivery device
  • Cytotoxic agent and enzyme for cancer treatment  
  • Drug and drainage device for glaucoma treatment
  • Drug and delivery system for localized bladder treatment
  • Drug and device for ex vivo photodynamic cancer treatment
  • Hormone to induce expression of breast fluids and sample collection device
  • Enzymatic debriding agent/dressing for wound management  
  • Insulin and inhaler to treat diabetes
  • Synthetic drug with controlled-delivery device for ophthalmic use
  • Chemical agent and delivery system for gallstone dissolution
  • Chlorhexidine gluconate swabs  
  • Radiolabeled contrast agent, production device and administration set 
  • Aerosolized radiolabeled contrast agent and production device
  • Radiopharmaceutical and carrier for orthopedic use
  • Drug and delivery system for internal tissue
  • Photopheresis system and drug to treat skin cancer
  • Drug, antibody and enzyme for cancer treatment
  • PET drug and probe for tumor localization
  • Topical drug and light source to treat skin cancer
  • Patient-controlled transdermal system for pain management
  • Drug and light source for dental use
  • Drug and collagen combination for pain relief after lumbar surgery
  • Aerosolized sodium chloride for halotherapy
  • Prefilled insulin cartridges for use with a dedicated infusion pump
  • Drug-eluting device to prevent restenosis of vascular grafts
  • Condom with drug-containing gel to help maintain erection
  • Cytotoxic agent-monoclonal antibody conjugate for cancer treatment
  • Cartridges with prefilled syringes for use in specified reusable autoinjector

 

D. Combination Products with Biological Product Primary Mode of Action

 

  • Cytotoxic monoclonal antibodies with device to remove excess antibodies from patient
  • Bone morphogenetic proteins and collagenous matrices for bone regeneration