Text Size

A A A

Search


 

Home | Clinical Trials

FDA Approved Drugs » Therapeutic Areas

View By:Year | Company | Conditions | Therapeutic Areas | Drug Names

FDA Approved Drugs by Therapeutic Area

Search by therapeutic area for drugs approved by the Food and Drug Administration (FDA) for sale in the United States. Click on an area below to view the complete list of drugs in that category or review descriptions for our therapeutic area list to assist you in your search.

Find out more about the types of drugs included in this listing.

FDA Approved Drugs for Pediatrics/Neonatology

Drugs Approved in 2014

Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; Biogen Idec; For the treatment of hemophilia B, Approved March 2014

Qudexy XR (topiramate); Upsher-Smith Laboratories; For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome, Approved March 2014

Vimizim (elosulfase alfa); BioMarin; For the treatment of Mucopolysaccharidosis type IVA, Approved February 2014

Drugs Approved in 2013

Actemra (ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013

Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013

Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved January 2013

Kynamro (mipomersen sodium); Genzyme; For the treatment of homozygous familial hypercholesterolemia, Approved January 2013

Ravicti (glycerol phenylbutyrate); Hyperion Therapeutics; For the treatment of pediatrics and adults with urea cycle disorders, Approved February 2013

Tivicay (dolutegravir); ViiV HealthCare; For the treatment of HIV-1 in adults and children over 12 years of age, Approved August 2013

Trokendi XR (topiramate); Supernus Pharmaceuticals; For the treatment of partial onset, tonic-clonic and Lennox-Gastaut Syndrome seizures, Approved August 2013

Drugs Approved in 2012

Fycompa (perampanel); Eisai; For the treatment of partial-onset seizures with or without secondarily generalized seizures, Approved October 2012

Oxtellar XR (oxcarbazepine extended release); Supernus Pharmaceuticals; For the adjunctive therapy of partial seizures in adults and in children 6 years to 17 years of age, Approved October 2012

Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceutical; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012

Quillivant XR (methylphenidate hydrochloride); NextWave Pharmaceuticals; For the treatment of Attention Deficit Hyperactivity Disorder, Approved September 2012

Sklice (ivermectin) lotion; Sanofi Pasteur; For the treatment of head lice, Approved February 2012

Surfaxin (lucinactant); Discovery Laboratories; For the treatment of respiratory distress syndrome in premature infants, Approved March 2012

Drugs Approved in 2011

Actemra (tocilizumab); Genentech; For the treatment of systemic juvenile idiopathic arthritis, Approved April 2011

Daliresp (roflumilast); Forest Pharmaceuticals; For the treatment of chronic obstructive pulmonary disease, Approved February 2011

Onfi (clobazam); Lundbeck; For the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome, Approved October 2011

Drugs Approved in 2010

Cuvposa (glycopyrrolate); Shionogi; For the treatment of chronic severe drooling in pediatrics with neurologic conditions, Approved July 2010

Dulera (mometasone furoate + formoterol fumarate dihydrate); Merck; For the treatment of asthma, Approved June 2010

Kapvay (clonidine hydrochloride); Shionogi; For the treatment of attention deficit hyperactivity disorder, Approved October 2010

Veltin (clindamycin phosphate and tretinoin); Stiefel; For the treatment of acne vulgaris, Approved July 2010

Drugs Approved in 2009

Berinert (C1 Esterase Inhibitor (Human)); CSL Behring; For the treatment of abdominal or facial attacks of hereditary angioedema, Approved October 2009

Colcrys (colchicine); Mutual Pharmaceuticals; For gout flares and familial Mediterranean fever, Approved October 2009

Hiberix (Haemophilus b Conjugate Vaccine; Tetanus Toxoid Conjugate); GlaxoSmithKline; For the prevention of invasive disease caused by Haemophilus influenzae type b., August of 2009

Ilaris (canakinumab); Novartis; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved June 2009

Intuniv (guanfacine extended-release); Shire Pharmaceuticals; For the treatment of ADHD in children and adolescents, Approved September 2009

Sabril (vigabatrin); Lundbeck; For the treatment of infantile spasms and complex partial seizures, Approved August 2009

Drugs Approved in 2008

Accretropin (somatropin rDNA Original); Cangene; For the treatment of growth failure in pediatrics, Approved January 2008

Alvesco (ciclesonide); Nycomed; For the maintenance treatment of asthma as prophylactic therapy in adults and adolescents, Approved January 2008

Aptivus (tipranavir); Boehringer Ingelheim; For the treatment of HIV, Approved June 2008

Banzel (rufinamide); Elan Pharmaceuticals; For the treatment of seizures associated with Lennox-Gastaut syndrome in pediatrics and adults, Approved November 2008

Cinryze (C1 Inhibitor (Human)); Lev Pharmaceuticals; For the treatment of angioedema attacks in adolescents/adults with Hereditary Angioedema, Approved October 2008

Moxatag (amoxicillin); MiddleBrooke Pharmaceuticals; For the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatrics, Approved January 2008

Orencia (abatacept); Bristol-Myers Squibb; For the treatment of Juvenile Idiopathic Arthritis, Approved April 2008

Patanase (olopatadine hydrochloride); Alcon; For the treatment of seasonal allergic rhinitis, Approved April 2008

Rotarix (Rotavirus Vaccine, Live, Oral); GlaxoSmithKline; For the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in pediatrics, Approved April 2008

Drugs Approved in 2007

Altabax (retapamulin); GlaxoSmithKline; For the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes, Approved April 2007

Supprelin LA (histrelin acetate); Indevus Pharmaceuticals; For the treatment of central precocious puberty, Approved May 2007

Veramyst (fluticasone furoate); GlaxoSmithKline; For the treatment of seasonal and perennial allergic rhinitis, Approved April 2007

Vyvanse (Lisdexamfetamine Dimesylate); New River; For the treatment of Attention-Deficit/Hyperactivity Disorder, Approved February 2007

Xyzal (levocetirizine dihydrochloride); UCB; For the treatment of seasonal and perennial allergic rhinitis and urticaria, Approved May 2007

Zingo (lidocaine hydrochloride monohydrate); Anesiva; For local analgesia prior to venipuncture or peripheral intravenous cannulation, in children 3 to 18 years of age, Approved August 2007

Drugs Approved in 2006

Desonate (desonide); Dow Pharm; For the treatment of atopic dermatitis, Approved October 2006

Elaprase (idursulfase); Shire Pharmaceuticals; For the treatmenr of mucopolysaccharidosis II (Hunter Syndrome), Approved July 2006

Myozyme (alglucosidase alfa); Genzyme; For the treatment of Pompe disease (glycogen storage disease type II), Approved April 2006

Drugs Approved in 2003

Aldurazyme (laronidase); Genzyme; For the treatment of Mucopolysaccharidosis I (MPS I) in subjects aged 5 to 65, Approved May 2003

Drugs Approved in 2002

Alinia (nitazoxanide); Romark Laboratories; For the treatment Diarrhea caused by Cryptosporidium and Giardia in children., December 2002

Daptacel; Sanofi Pasteur; Pediatric vaccine for immunization against diptheria, tetanus and pertussis, Approved May 2002

Fluzone Preservative-free; Sanofi Pasteur; Preservative free, pediatric dose, influenza virus vaccine for the immunization of infants, Approved September 2002

Orfadin (nitisinone); Orphan Pharmaceuticals; Capsules for the treatment of hereditary tyrosinemia type I, Approved January 2002

Pediarix Vaccine; GlaxoSmithKline; For the prevention of diphtheria, tetanus, pertussi, polio and hepatitis B in children 6 weeks to 7 years old., Approved December 2002

Qvar (beclomethasone dipropionate); Ivax; For the treatment of asthma, Approved May 2002

Ritalin LA (methylphenidate HCl); Novartis; Oral capsules for the treatment Attention-Deficit/Hyperactivity Disorder (ADHD), Approved June 2002

Strattera (atomoxetine HCl); Eli Lilly; For the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents and adults., December 2002

Drugs Approved in 2001

Adderall XR; Shire Pharmaceuticals; Once-daily medication for the treatment of attention deficit/hyperactivity disorder (ADHD), Approved October 2001

Focalin (dexmethylphenidate HCl); Celgene; For the treatment of attention deficit hyperactivity disorder (ADHD), Approved November 2001

Genotropin (somatropin) injection; Pharmacia & Upjohn; For the treatment of growth failure in children who were born small for gestational age (SGA), Approved July 2001

Metadate CD; Celltech Pharmaceuticals; Oral capsules for the treatment of attention deficit hyperactivity disorder, Approved April 2001

NasalCrom Nasal Spray; Pharmacia & Upjohn; Over-the-counter nasal spray for treatment of all nasal allergy symptoms, Approved April 2001

Drugs Approved in 2000

Kogenate FS (Antihemophilic Factor Recombinant); Bayer; For the treatment of hemophilia A, Approved June 2000

Lantus (insulin glargine [rDNA origin] injection); Sanofi-aventis; For the treatment of type I and type II diabetes mellitus in adults and pediatrics, Approved April 2000

Lantus (insulin glargine [rDNA origin] injection); Sanofi-aventis; For adults and children w/Type 1 diabetes, or adults w/Type 2 diabetes requiring basal insulin to control hyperglycemia, Approved April 2000

Neurontin (gabapentin) oral solution; Parke-Davis; For the treatment of partial seizures in pediatric patients three years of age and older, Approved October 2000

Trileptal (oxcarbazepine) Tablets; Novartis; Approved for use as adjunctive therapy in the treatment of partial seizures in children (monotherapy for adults), Approved January 2000

Drugs Approved in 1999

Amoxil (amoxicillin); SmithKline Beecham; Treatment (antibiotic) for common bacteria, Approved July 1999

Topamax (topiramate); Ortho-McNeil Pharmaceutical; Treatment for epilepsy in pediatric patients, Approved July 1999

Drugs Approved in 1998

Curosurf; Dey Laboratories; Treatment for respiratory distress syndrome in premature infants., Approved October 1998

Cylert; Abbott Laboratories; Treatment for Attention Deficit Disorder, Approved October 1998

Desmopressin Acetate (DDAVP); Rhone Poulenc Rorer; Treatment for nocturnal enuresis, Approved March 1998

Infasurf; ONY; For the prevention and treatment of Respiratory Distress Syndrome (RDS) in premature infants, Approved July 1998.

Pulmozyme (dornase alfa); Genentech; Treatment for cystic fibrosis, Approved March 1998

Rocephin; Roche; Treatment for pediatric otitis media, Approved January 1998

Singulair; Merck; Treatment for asthma, Approved February 1998

Timentin; SmithKline Beecham; Treatment for wide range of infections in children, Approved January 1998

Viroptic; King Pharmaceuticals; Treatment for inflammation of the cornea in children due to herpes simplex virus, Approved February 1998

Drugs Approved in 1997

INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed); SmithKline Beecham; Treatment for diphtheria, tetanus and pertussis (whooping cough) in infants and children, January 1997

AneuVysion Assay; Vysis; Genetic test for birth defects, Approved October 1997

Antizol Injection; Orphan Medical; Treatment for ethylene glycol poisoning, Approved December 1997

Flovent Rotadisk; GlaxoSmithKline; Treatment of asthma in patients four and older, Approved November 1997

Floxin otic; Daiichi Sankyo; Treatment for otitis media, Approved December 1997

Geref (sermorelin acetate for injection); Serono Laboratories; Treatment for pedicatric growth disorder, Approved October 1997

Norditropin (somatropin (rDNA origin) for injection); Novo Nordisk; Treatment of children who have growth failure, Approved February 1997

Norvir (ritonavir); Abbott Laboratories; Treatment for HIV infection, Approved March 1996/March 1997

Omnicef; Warner-Lambert; Treatment against various bacterias, Approved December 1997

Tilade (nedocromil sodium); Rhone Poulenc Rorer; Treatment for mild-to-moderate bronchial asthma, Approved April 1997

Tilade (nedocromil sodium); Rhone Poulenc Rorer; Treatment for asthma, Approved April 1997

Timentin; SmithKline Beecham; Treatment for septicemia, Approved December 1997

Tobi; PathoGenesis; Treatment for cystic fibrosis, Approved December 1997

VERSED (midazolam HCI); Roche; Treatment for sedating children who must undergo painful surgery, Approved March 1997

VIRACEPT (nelfinavir mesylate); Agouron Pharmaceuticals; Treatment for HIV infection in adults and children, Approved March 1997

Zerit (stavudine); Bristol-Myers Squibb; Treatment for infants and children infected with HIV, Approved January 1997

Zoloft (sertraline HCl); Pfizer; Treatment of panic disorder in children ages 6-17, Approved October 1997

Drugs Approved in 1996

Adderall (mixed salts of a single-entity amphetamine); Richwood Pharmaceutical; Treatment for attention-deficit/hyperactivity disorder, Supplemental NDA Approved February 1996

Children's Advil (pediatric ibuprofen); Whitehall-Robins Healthcare; Treatment of fever and minor aches and pains, Approved July 1996

Claritin Syrup (loratadine); Schering-Plough; Treatment for children with seasonal allergies, Approved October 1996

Havrix; SmithKline Beecham; Treatment for hepatitis A, Approved March 1996

Merrem I.V. (meropenem); AstraZeneca; Treatment for intra-abdominal infections and bacterial meningitis, Approved June 1996

RespiGam (Respiratory Syncitial Virus Immune Globulin Intravenous); MedImmune; Treatment for the prevention of respiratory syncytial virus disease, Approved January 1996

Tegretol (carbamazepine); Ciba Pharmaceuticals; Treatment for young children with epilepsy, Approved March 1996

Tripedia (Diptheria and Tetanus Toxoids and Acellular Pertussis Vaccine Absorbed); Connaught Laboratories; Treatment for whooping cough, Approved August 1996


 Back to Top | Printer Friendly Version

Get Involved

Stroke and You

Our Mission Statement

National Stroke Association’s mission is to reduce the incidence and impact of stroke by developing compelling education and programs focused on prevention, treatment, rehabilitation and support for all impacted by stroke.

National Stroke Association

1-800-STROKES
1-800-787-6537
9707 E. Easter Lane, Suite B
Centennial, CO 80112
info@stroke.org