CDER Priority Drug and Biologic Approvals in Calendar Year 2005

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CDER Priority Drug and Biologic Approvals in Calendar Year 2005
Updated through December 31, 2005

Priority New Drug Application (NDA) Approvals:

NDA Number	Proprietary Name	Established Name	Applicant	Chemical Type	Review Classification	Approval Date	Indication
N021841	Lamivudine; Zidovudine; Nevirapine	Lamivudine; Zidovudine; Nevirapine	Pharmacare	4	P	24-Jan-05*	Lamivudine; Zidovudine; Nevirapine is indicated for treatment of HIV-1 infection.
N020645	Ammonul	Sodium Benzoate; Sodium Phenylacetate	Ucyclyd Pharma	5	P, O	17-Feb-05	Ammonul is indicated as an adjunctive therapy in the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle.
N021506	Mycamine	Micafungin Sodium	Fujisawa	1	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	1	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.
N021797	Baraclude	Entecavir	Bristol Myers Squibb	3	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.
N021737	Retisert	Fluocinolone Acetonide	Bausch & Lomb	3	P, O	08-Apr-05	Retisert is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.
N021845	Revatio	Sildenafil Citrate	Pfizer	5	P	03-Jun-05	Revatio is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) to improve exercise ability. The efficacy of Revatio has not been evaluated in patients currently on bosentan therapy.
N021821	Tygacil	Tigecycline	Wyeth Pharms	1	P	15-Jun-05	Tygacil is indicated for the treatment of Complicated Skin and Skin Structure Infections (cSSSI) and Complicated Intra-abdominal Infections (cIAI).
N021814	Aptivus	Tipranavir	Boehringer Ingelheim	1	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.
N021862	Nevanac	nepafenac	Alcon	1	P	19-Aug-05	Nevanac is indicated for the treatment of pain and inflammation associated with cataract surgery.
N021839	Increlex	mecasermin (rDNA origin)	Tercica	1	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.
N021896	Emtriva	Emtricitabine	Gilead	3	P	28-Sep-05	Emtriva is indicated in combination with other antiretroviral agents, for the treatment of HIV-1 infection in patients over three months of age.
N021716	Hydase	Hyaluronidase	PrimaPharm	1	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	1	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.
N021906	Kaletra	Lopinavir; Ritonavir	Abbott Labs	3	P	28-Oct-05	Kaletra in combination with other antiretroviral agents, is indicated for the treatment of HIV-infection.
N021882	Exjade	Deferasirox	Novartis	1	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	1	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	1, 4	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	1	P, O	20-Dec-05	Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma.
N021880	Revlimid	Lenalidomide	Celgene	1	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.

Priority 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.

NDA Chemical Type:
1 -   New molecular entity
2 -   New ester, new salt, or other noncovalent derivative
3 -   New formulation
4 -   New combination
5 -   New manufacturer
7 -   Drug already marketed, but without an approved NDA

Review Classification:
P - Priority Review - Significant improvement compared to marketed products, in the treatment, diagnosis, or prevention of a disease.
O - Orphan Designation - Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).

* NDA 21841, Lamivudine; Zidovudine; Nevirapine Co-Packaged was tentatively approved on January 24, 2005 under the President's Emergency Plan for Aids Relief (PEPFAR).

To access approval letters, labels, and review packages, go to

Date created: March 7, 2005; updated April 07, 2006