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