2006 FDA Approvals

Veregen^TM – kunecatechins – approved 10/31/2006

Provides for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older. 

 

Tyzeka^TM – telbivudine – approved 10/25/2006

For the treatment of adults with chronic hepatitis B.

 

Omnaris^TM – ciclesonide – approved 10/20/2006

For the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis (also known as hay fever).

 

Albumin® (human) – approved 10/17/2006

To restore and maintain circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate.

 

Januvia^TM – sitagliptin phosphate – approved 10/16/2006

To improve blood sugar levels in patients with type 2 diabetes, alone or in combination with two other commonly prescribed oral diabetes medications, metformin or a PPAR (peroxisome proliferator-activated receptor gamma) agonist.

 

Zolinza® – vorinostat – approved 10/6/2006

For the treatment of cutaneous T-cell lymphoma (CTCL), a type of skin cancer, to be used when the disease persists, gets worse, or comes back during or after treatment with other medicines.

 

FluLaval^TM – influenza vaccine – approved 10/5/2006

To immunize people 18 years of age and older against the disease caused by strains of influenza virus judged likely to cause seasonal flu in the Northern Hemisphere in 2006-2007.

 

Pylera® – biskalcitrate; metronidazole; tetracycline – approved 9/28/2006

Provides for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.

 

Vectibix^TM – panitumumab – approved 9/27/2006

Provides for the treatment of EGFR-expressing metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine, oxaliplatin, and irinotecan containing chemotherapy regimens.

 

Noxafil® – posaconazole – approved 9/15/2006

Provides for the treatment of prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with Graft versus Host Disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy; also indicated for the treatment of oropharyngeal candidiasis (OPC), including infections refractory to itraconazole and/or fluconazole.

 

Elaprase^TM – idursulfase – approved 7/24/2006

For the treatment of patients with Hunter syndrome (Mucopolysaccharidosis II).

 

Anthelios SX – ecamsule; avobenzone; octocrylene – approved 7/21/2006

For the prevention of sunburn and to help provide protection from UVA and UVB rays.

 

Lucentis® – ranibizumab – approved 6/30/2006

For the treatment of wet age-related macular degeneration.

 

Sprycel^TM – dasatinib – approved 6/29/2006

For the treatment of chronic myeloid leukemia in patients who are no longer responding to, or cannot tolerate, imatinib (Gleevec); treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia in patients who are no longer responding to, or cannot tolerate, other therapies.

 

Prezista^TM – darunavir – approved 6/23/2006

For the treatment of HIV in adults who have not responded to other treatments; to be administered with low-dose ritonavir and other anti-HIV agents.

 

Gardasil® – Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine – approved 6/8/2006

For use in females 9 to 26 years of age for prevention of the following diseases caused by Human Papillomavirus (HPV) Types 6, 11, 16, 18: cervical cancer; genital warts; and the following precancerous or dysplastic lesions: cervical adenomcarcinoma in situ; cervical intraepithelial neoplasia (CIN) grade 2 and grade 3; vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3; vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3; cervical intraepithelial neoplasia (CIN) grade 1.

 

Zostavax® – Zoster vaccine, live – approved 5/25/2006

For the prevention of shingles in people 60 years of age and older.

 

Azilectrasagiline® – approved 5/17/2006

For the treatment of Parkinson's disease as an initial single drug therapy; also can be used as an addition to levodopa.

 

Chantixvarenicline^TM – approved 5/11/2006

For smoking cessation.

 

Dacogen® – decitabine – approved 5/2/2006

For the treatment of myelodysplastic syndromes (MDS).

 

Myozyme® – alglucosidase alfa – approved 4/28/2006

For the treatment of Pompe disease (GAA deficiency).

 

Eraxis^TM – anidulafungin – approved 2/17/2006

For the treatment of Candida (a type of fungus) infections in the blood stream, esophagus, abdominal cavity and intra-abdominal abscesses.

 

RotaTeq® – rotavirus vaccine, live, oral, pentavalent – approved 2/3/2006

For the prevention of rotavirus gastroenteritis in infants.

 

Amitiza® – lubiprostone – approved 1/31/2006

For the treatment of chronic idiopathic constipation in adults.

 

Ranexa® – ranolazine – approved 1/27/2006

For the treatment of chronic angina.

 

HepaGam B^TM – hepatitis B immune globulin (human) – approved 1/27/2006

For the treatment of acute exposure to blood containing hepatitis B antigen, perinatal exposure of infants born to hepatitis-B positive mothers, sexual exposure to hepatitis B positive persons, and household exposure to persons with acute HBV infection.

 

Sutent® – sunitinib – approved 1/26/2006

For the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib (Gleevec); treatment of advanced kidney cancer.

Vivaglobin® – immune globulin subcutaneous (human) – approved 1/9/2006

For the treatment of patients with primary immunodeficiency.