FDA Approved Drugs for Pediatrics/Neonatology

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

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