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