Approved Drugs for Pediatrics/Neonatology

Drugs Approved in 2008

• Accretropin (somatropin rDNA Original); For the treatment of growth failure in pediatrics; Cangene Corp; Approved January 2008
• Alvesco (ciclesonide); For the maintenance treatment of asthma as prophylactic therapy in adults and adolescents; Nycomed; Approved January 2008
• Aptivus (tipranavir); For the treatment of HIV; Boehringer Ingelheim; Approved June 2008
• Cinryze (C1 Inhibitor (Human)); For the treatment of angioedema attacks in adolescents/adults with Hereditary Angioedema; Lev Pharmaceuticals; Approved October 2008
• Moxatag (amoxicillin); For the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatrics; MiddleBrooke Pharmaceuticals; Approved January 2008
• Orencia (abatacept); For the treatment of Juvenile Idiopathic Arthritis; Bristol-Myers Squibb; Approved April 2008
• Patanase (olopatadine hydrochloride); For the treatment of seasonal allergic rhinitis; Alcon; Approved April 2008
• Rotarix (Rotavirus Vaccine, Live, Oral); For the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in pediatrics; GlaxoSmithKline; Approved April 2008

Drugs Approved in 2007

• Altabax (retapamulin); For the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes; Glaxo; Approved April 2007
• Supprelin LA (histrelin acetate); For the treatment of central precocious puberty; Indevis Pharms; Approved May 2007
• Veramyst (fluticasone furoate); For the treatment of seasonal and perennial allergic rhinitis; GlaxoSmithKline; Approved April 2007
• Vyvanse (Lisdexamfetamine Dimesylate); For the treatment of Attention-Deficit/Hyperactivity Disorder; New River; Approved February 2007
• Xyzal (levocetirizine dihydrochloride); For the treatment of seasonal and perennial allergic rhinitis and urticaria; UCB Inc.; Approved May 2007
• Zingo (lidocaine hydrochloride monohydrate); For local analgesia prior to venipuncture or peripheral intravenous cannulation, in children 3 to 18 years of age; Anesiva; Approved August 2007

Drugs Approved in 2006

• Desonate (desonide); For the treatment of atopic dermatitis; Dow Pharm; Approved October 2006
• Elaprase (idursulfase); For the treatmenr of mucopolysaccharidosis II (Hunter Syndrome); Shire Pharmaceuticals; Approved July 2006
• Myozyme (alglucosidase alfa); For the treatment of Pompe disease (glycogen storage disease type II); Genzyme; Approved April 2006

Drugs Approved in 2005

Drugs Approved in 2004

Drugs Approved in 2003

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

Drugs Approved in 2002

• Alinia (nitazoxanide); For the treatment Diarrhea caused by Cryptosporidium and Giardia in children.; Romark Laboratories; December 2002
• Daptacel; Pediatric vaccine for immunization against diptheria, tetanus and pertussis; Aventis Pasteur; Approved May 2002
• Fluzone Preservative-free; Preservative free, pediatric dose, influenza virus vaccine for the immunization of infants; Aventis Pasteur; Approved September 2002
• Orfadin (nitisinone); Capsules for the treatment of hereditary tyrosinemia type I; Orphan Pharmaceuticals; Approved January 2002
• Pediarix Vaccine; For the prevention of diphtheria, tetanus, pertussi, polio and hepatitis B in children 6 weeks to 7 years old.; GlaxoSmithKline; Approved December 2002
• Qvar (beclomethasone dipropionate); For the treatment of asthma; Ivax; Approved May 2002
• Ritalin LA (methylphenidate HCl); Oral capsules for the treatment Attention-Deficit/Hyperactivity Disorder (ADHD); Novartis; Approved June 2002
• Strattera (atomoxetine HCl); For the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents and adults.; Eli Lilly; December 2002

Drugs Approved in 2001

• Adderall XR; Once-daily medication for the treatment of attention deficit/hyperactivity disorder (ADHD); Shire Pharmaceuticals; Approved October 2001
• Focalin (dexmethylphenidate HCl); For the treatment of attention deficit hyperactivity disorder (ADHD); Celgene; Approved November 2001
• Genotropin (somatropin); For the treatment of growth failure in children who were born small for gestational age (SGA); Pharmacia; Approved July 2001
• Metadate CD; Oral capsules for the treatment of attention deficit hyperactivity disorder; Celltech Pharmaceuticals; Approved April 2001
• NasalCrom Nasal Spray; Over-the-counter nasal spray for treatment of all nasal allergy symptoms; Pharmacia; Approved April 2001

Drugs Approved in 2000

• Lantus (insulin glargine [rDNA origin] injection); For adults and children w/Type 1 diabetes, or adults w/Type 2 diabetes requiring basal insulin to control hyperglycemia; Aventis Pharmaceuticals; Approved April 2000
• Neurontin (gabapentin) Oral Solution; For the treatment of partial seizures in pediatric patients three years of age and older; Parke-Davis; Approved October 2000
• Trileptal (oxcarbazepine) Tablets; Approved for use as adjunctive therapy in the treatment of partial seizures in children (monotherapy for adults); Novartis; Approved January 2000

Drugs Approved in 1999

• Amoxil (amoxicillin); Treatment (antibiotic) for common bacteria; SmithKline Beecham; Approved July 1999
• Topamax; Treatment for epilepsy in pediatric patients; Ortho-McNeil Pharmaceutical; Approved July 1999

Drugs Approved in 1998

• Curosurf; Treatment for respiratory distress syndrome in premature infants.; Dey Laboratories; Approved October 1998
• Cylert; Treatment for Attention Deficit Disorder; Abbott Laboratories; Approved October 1998
• DDAVP (tablet formulation); Treatment for nocturnal enuresis; Rhone Poulenc Rorer; Approved March 1998
• Infasurf; For the prevention and treatment of Respiratory Distress Syndrome (RDS) in premature infants; ONY; Approved July 1998.
• Pulmozyme Inhalation Solution; Treatment for cystic fibrosis; Genentech; Approved March 1998
• Rocephin; Treatment for pediatric otitis media; Roche; Approved January 1998
• Rocephin; Treatment for acute otitis media; Roche; Approved January 1998
• Singulair; Treatment for asthma; Merck; Approved February 1998
• Timentin; Treatment for wide range of infections in children; SmithKline Beecham; Approved January 1998
• Viroptic; Treatment for inflammation of the cornea in children due to herpes simplex virus; King Pharmaceuticals; Approved February 1998

Drugs Approved in 1997

• INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed); Treatment for diphtheria, tetanus and pertussis (whooping cough) in infants and children; SmithKline Beecham; January 1997
• AneuVysion Assay; Genetic test for birth defects; Vysis; Approved October 1997
• Antizol Injection; Treatment for ethylene glycol poisoning; Orphan Medical; Approved December 1997
• Flovent Rotadisk; Treatment of asthma in patients four and older; GlaxoWellcome; Approved November 1997
• Floxin otic; Treatment for otitis media; Daiichi Pharmaceutical; Approved December 1997
• Geref (sermorelin acetate for injection); Treatment for pedicatric growth disorder; Serono Laboratories; Approved October 1997
• Nasacort AQ (triamcinolone acetonide) Nasal Spray; Treatment of nasal symptoms of seasonal allergic rhinitis in children Aged 6-11; Phone-Poulenc Rorer; Approved October 1997
• Norditropin (somatropin (rDNA origin) for injection); Treatment of children who have growth failure; Novo Nordisk; Approved February 1997
• Omnicef; Treatment against various bacterias; Warner-Lambert; Approved December 1997
• Tilade; Treatment for asthma; Rhone Poulenc Rorer; Approved April 1997
• Tilade (nedocromil sodium) inhaler; Treatment for mild-to-moderate bronchial asthma; Rhone Poulenc Rorer; Approved April 1997
• Timentin; Treatment for septicemia; SmithKline Beecham; Approved December 1997
• Tobi; Treatment for cystic fibrosis; PathoGenesis; Approved December 1997
• VERSED (midazolam HCI); Treatment for sedating children who must undergo painful surgery; Roche; Approved March 1997
• VIRACEPT (nelfinavir mesylate); Treatment for HIV infection in adults and children; Agouron Pharmaceuticals; Approved March 1997
• Zerit (stavudine, d4T); Treatment for infants and children infected with HIV; Bristol-Myers Squibb; Approved January 1997
• Zoloft; Treatment of panic disorder in children ages 6-17; Pfizer; Approved October 1997

Drugs Approved in 1996

• Adderall (mixed salts of a single-entity amphetamine); Treatment for attention-deficit/hyperactivity disorder; Richwood Pharmaceutical; Supplemental NDA Approved February 1996
• Children's Advil (pediatric ibuprofen); Treatment of fever and minor aches and pains; Whitehall-Robins Healthcare; Approved July 1996
• Claritin Syrup (loratadine); Treatment for children with seasonal allergies; Schering-Plough; Approved October 1996
• Havrix; Treatment for hepatitis A; SmithKline Beecham; Approved March 1996
• Merrem I.V. (meropenem); Treatment for intra-abdominal infections and bacterial meningitis; Zeneca Pharmaceuticals; Approved June 1996
• Norvir (ritonavir); Treatment for HIV infection; Abbott Laboratories; Approved March 1996/March 1997
• RespiGam (Respiratory Syncitial Virus Immune Globulin Intravenous); Treatment for the prevention of respiratory syncytial virus disease; MedImmune; Approved January 1996
• Tegretol (carbamazepine USP); Treatment for young children with epilepsy; Ciba Pharmaceuticals; Approved March 1996
• Tripedia (Diptheria and Tetanus Toxoids and Acellular Pertussis Vaccine Absorbed); Treatment for whooping cough; Connaught Laboratories; Approved August 1996

Drugs Approved in 1995