Description of Medical Areas
About the FDA Approved Listings
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Drugs Approved by the FDA (2002)
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The following drugs have been approved this year by
the Food and Drug Administration.
Cardiology/Vascular Diseases
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Benicar; Oral tablet for the treatment of hypertension; Sankyo Pharma; Approved April 2002 Remodulin (treprostinil); For the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms; United Therapeutics; Approved May 2002
Dental/Maxillofacial Surgery
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Dermatology/Plastic Surgery
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Benicar; Oral tablet for the treatment of hypertension; Sankyo Pharma; Approved April 2002 Forteo (teriparatide); For the treatment of Osteoporosis in postmenopausal women and men who are at high risk for a fracture.; Eli Lilly; December 2002 Levo-T (levothyroxine sodium); Indicated for the treatment of hypothyroidism and the suppression of thyroid stimulating hormone; Mova Pharmaceutical; Approved March 2002 Synthroid (levothyroxine sodium); For replacement or supplemental therapy for hypothyroidism and pituitary thyroid stimulating hormone suppression; Abbott Laboratories; Approved July 2002 Testim; External cream for the treatment of male hormone deficiency.; Auxilium Pharmaceuticals; Approved October 2002
Alinia (nitazoxanide); For the treatment Diarrhea caused by Cryptosporidium and Giardia in children.; Romark Laboratories; December 2002 Hepsera (adefovir dipivoxil); For the treatment of chronic hepatitis B in adults with evidence of active viral replication; Gilead Sciences; Approved September 2002 Orfadin (nitisinone); Capsules for the treatment of hereditary tyrosinemia type I; Orphan Pharmaceuticals; Approved January 2002 SecreFlo (secretin); To aid in the diagnosis of pancreatic dysfunction and gastrinoma; Repligen; Approved April 2002 Zelnorm (tegaserod maleate) Tablets; For the short-term treatment of irritable bowel syndrome in women whose primary bowel symptom is constipation; Novartis; Approved July 2002 Zelnorm (tegaserod maleate) Tablets; For the short-term treatment of irritable bowel syndrome in women whose primary bowel symptom is constipation; Novartis; Approved July 2002
Neulasta; Treatment to decrease the chance of infection by febrile neutropenia in patients receiving chemotherapy; Amgen; Approved January 2002
Immunology/Infectious Diseases
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Alinia (nitazoxanide); For the treatment Diarrhea caused by Cryptosporidium and Giardia in children.; Romark Laboratories; December 2002 Clarinex; Once-daily oral tablet for the treatment of allergic rhinitis and chronic ideopathic urticaria; Schering-Plough; Approved February 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 Hepsera (adefovir dipivoxil); For the treatment of chronic hepatitis B in adults with evidence of active viral replication; Gilead Sciences; Approved September 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 Sustiva; Once-daily oral tablet for the the treatment of HIV infection; Bristol-Myers Squibb; Approved February 2002
Alora; Transdermal patch for the prevention of postmenopausal osteoporosis and treatment of vasomotor menopausal symptoms; Watson Pharmaceuticals; Approved April 2002 Avinza (morphine sulfate); Extended release capsule for the relief of pain requiring continuous, around-the-clock therapy; Elan; Approved March 2002 Forteo (teriparatide); For the treatment of Osteoporosis in postmenopausal women and men who are at high risk for a fracture.; Eli Lilly; December 2002 Remicade; Intravenous infusion for the treatment of rheumatoid arthritis; Centocor; Approved February 2002 Testim; External cream for the treatment of male hormone deficiency.; Auxilium Pharmaceuticals; Approved October 2002 Vioxx (rofecoxib); For the treatment of rheumatoid arthritis; Merck; Approved April 2002 -- UPDATED: WITHDRAWN OCTOBER 2004
Mesnex; Oral tablet to inhibit the hemorrhagic cystitis induced by Ifex (ifosfamide); Bristol-Myers Squibb, Baxter Healthcare; Approved March 2002
Avinza (morphine sulfate); Extended release capsule for the relief of pain requiring continuous, around-the-clock therapy; Elan; Approved March 2002 Neurontin (gabapentin); Oral treatment for the management of post-herpetic neuralgia (PHN); Pfizer; Approved May 2002 Rebif (interferon beta-1a); Subcutaneous injection for the treatment of relapsing forms of multiple sclerosis; Serono Laboratories; Approved March 2002 Strattera (atomoxetine HCl); For the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents and adults.; Eli Lilly; December 2002 Xyrem (sodium oxybate); For the treatment of cataplexy, a sudden loss of muscle tone, associated with narcolepsy; Orphan Medical; Approved July 2002
Alora; Transdermal patch for the prevention of postmenopausal osteoporosis and treatment of vasomotor menopausal symptoms; Watson Pharmaceuticals; Approved April 2002 Forteo (teriparatide); For the treatment of Osteoporosis in postmenopausal women and men who are at high risk for a fracture.; Eli Lilly; December 2002 Zoloft (sertraline HCl); Oral tablets for the treatment of premenstrual dysphoric mood disorder (PMDD); Pfizer; Approved May 2002
Faslodex (fulvestrant); For the treatment of hormone receptor positive metastatic breast cancer; AstraZeneca; Approved April 2002 Neulasta; Treatment to decrease the chance of infection by febrile neutropenia in patients receiving chemotherapy; Amgen; Approved January 2002 SecreFlo (secretin); To aid in the diagnosis of pancreatic dysfunction and gastrinoma; Repligen; Approved April 2002 Zometa (zoledronic acid); For the treatment of multiple myeloma and bone metastases from solid tumors; Novartis; Approved February 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 Strattera (atomoxetine HCl); For the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents and adults.; Eli Lilly; December 2002
Mesnex; Oral tablet to inhibit the hemorrhagic cystitis induced by Ifex (ifosfamide); Bristol-Myers Squibb, Baxter Healthcare; Approved March 2002
Abilify (aripiprazole); Oral drug for the treatment of schizophrenia; Bristol-Myers Squibb, Otsuka America Pharmaceutical; Approved November 2002 Lexapro (escitalopram oxalate); An orally administered selective serotonin reuptake inhibitor useful for the treatment for major depressive disorder; Forest Laboratories; Approved August 2002 Paxil CR; Oral tablet for the treatment of depression and panic disorder; GlaxoSmithKline; Approved February 2002 Strattera (atomoxetine HCl); For the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents and adults.; Eli Lilly; December 2002 Zoloft (sertraline HCl); Oral tablets for the treatment of premenstrual dysphoric mood disorder (PMDD); Pfizer; Approved May 2002
Pulmonary/Respiratory Diseases
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Clarinex; Once-daily oral tablet for the treatment of allergic rhinitis and chronic ideopathic urticaria; Schering-Plough; Approved February 2002 Remodulin (treprostinil); For the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms; United Therapeutics; Approved May 2002 Xopenex; Inhaled solution for treatment of reversible obstructive airway disease; Sepracor; Approved February 2002
Humira (adalimumab); For the treatment of moderately to severely active rheumatoid arthritis; Abbott Laboratories; Approved December 2002 Remicade; Intravenous infusion for the treatment of rheumatoid arthritis; Centocor; Approved February 2002 Vioxx (rofecoxib); For the treatment of rheumatoid arthritis; Merck; Approved April 2002 -- UPDATED: WITHDRAWN OCTOBER 2004
Trauma/Emergency Medicine
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