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 CDER New Molecular Entity (NME) Drug and New Biologic Approvals in Calendar Year 2005
Updated through December 31, 2005

NME New Drug Application (NDA) Approvals:

NDA Number Proprietary Name Established Name Applicant Review Classification Approval Date Indication
N021332 Symlin Pramlintide Acetate Amylin S 16-Mar-05 Symlin is indicated for: (1) Type 1 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy. (2) Type 2 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy, with or without a concurrent sulfonylurea agent and/or metformin.
N021506 Mycamine Micafungin Sodium Fujisawa P 16-Mar-05 Mycamine is indicated for prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation.
N021797 Baraclude Entecavir Bristol Myers Squibb P 29-Mar-05 Baraclude is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
N021773 Byetta Exenatide Amylin S 28-Apr-05 Byetta is indicated to improve glycemic control in patients with type 2 diabetes mellitus who have not achieved adequate glycemic control on metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea.
N021821 Tygacil Tigecycline Wyeth Pharms P 15-Jun-05 Tygacil is indicated for the treatment of Complicated Skin and Skin Structure Infections (cSSSI) and Complicated Intra-abdominal Infections (cIAI).
N021536 Levemir Insulin Detemir Novo Nordisk S 16-Jun-05 Levemir is indicated for once or twice-daily subcutaneous administration in the treatment of adult patients with Type 1 or Type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.
N021814 Aptivus Tipranavir Boehringer Ingelheim P 22-Jun-05 Aptivus co-administered with 200 mg of ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infected adult patients with evidence of viral replication, who are highly treatment-experienced or have HIV-1 strains resistant to multiple protease inhibitors.
N021782 Rozerem Ramelteon Takeda Global S 22-Jul-05 Rozerem is indicated for the treatment of insomnia characterized by difficulty with sleep onset.
N021862 Nevanac Nepafenac Alcon P 19-Aug-05 Nevanac is indicated for the treatment of pain and inflammation associated with cataract surgery.
N021839 Increlex Mecasermin [rDNA origin] Tercica P, O 30-Aug-05 Increlex is indicated for the long-term treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed
neutralizing antibodies to growth hormone.
N021716 Hydase Hyaluronidase PrimaPharm P 25-Oct-05 Hydase is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs; for hypodermoclysis; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.
N021877 Arranon Nelarabine GlaxoSmithKline P, O 28-Oct-05 Arranon is indicated for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
N021882 Exjade Deferasirox Novartis P, O 02-Nov-05 Exjade is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.
N021859 Hylenex Recombinant Hyaluronidase Human Halozyme P 02-Dec-05 Hylenex recombinant is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs; for hypodermoclysis; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.
N021884 Iplex Mecasermin Rinfabate [rDNA Origin] Insmed P, O 12-Dec-05 Iplex is indicated for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone.
N021923 Nexavar Sorafenib Tosylate Bayer P, O 20-Dec-05 Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma.
N021880 Revlimid Lenalidomide Celgene P, O 27-Dec-05 Revlimid is indicated for the treatment of patients with transfusion dependent anemia due to low or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5 q cytogenetic abnormality with or without additional cytogenetic abnormalities.
N021697 Vaprisol Conivaptan Hydrochloride Astellas S 29-Dec-05 Vaprisol is indicated for the treatment of euvolemic hyponatremia in hospitalized patients.

New Biologic License Application (BLA) Approvals:

BLA Number Proprietary Name Proper Name Applicant Review Classification Approval Date Indication
BL125117 Naglazyme Galsulfase Biomarin Pharmaceutical Inc. P, O 31-May-05

Treatment of patients with Mucopolysaccharidosis VI (MPS VI)
BL125118 Orencia Abatacept Bristol-Myers Squibb P 23-Dec-05

Abatacept is indicated for reducing signs and symptoms, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease Modifying Anti-Rheumatoid Drugs (DMARDs), such as methotrexate or TNF antagonists.  Abatacept may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists.

Review Classification:  
P -   Priority Review - Significant improvement compared to marketed products, in the treatment, diagnosis, or prevention of a disease.
S -   Standard Review - Products that do not qualify for priority review.
O -  Orphan Designation - Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).

To access approval letters, labels, and review packages, go to Drugs at FDA Logo links back to Initial Search Page

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Date created: March 7, 2005; updated March 30, 2006

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