Approved Drugs for Pediatrics/Neonatology
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;
For the treatment of ADHD in children and adolescents, Approved September 2009
Sabril (vigabatrin); Lundbeck, Inc.;
For the treatment of infantile spasms and complex partial seizures, Approved August 2009
Accretropin (somatropin rDNA Original); Cangene Corp;
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
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
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
Aldurazyme (laronidase); Genzyme;
For the treatment of Mucopolysaccharidosis I (MPS I) in subjects aged 5 to 65, Approved May 2003
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
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;
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;
Over-the-counter nasal spray for treatment of all nasal allergy symptoms, Approved April 2001
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
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
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
Rocephin; Roche;
Treatment for acute 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
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
Nasacort AQ (triamcinolone acetonide) Nasal Spray; Phone-Poulenc Rorer;
Treatment of nasal symptoms of seasonal allergic rhinitis in children Aged 6-11, 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
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
