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