NME Drug and New Biologic Approvals in 2005
ME 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.
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).