|
Class |
Name/Company |
Approval Dates and Comments |
|
Antiviral Agent
|
Naturally-Derived Alpha Interferon
Viragen
|
The Swedish Regulatory Authorities approved expanded use in January 2002, to include the treatment of patients afflicted with any and all diseases in which patients were or became resistant to treatments using recombinant (synthetic) interferon. Recombinant interferons usually contain only one subtype of interferon as compared to multiple subtypes in naturally derived interferon, which is produced by human white blood cells.
|
|
HIV/AIDS
|
Efavirenz
Sustiva®
Bristol-Myers Squibb
|
The US FDA approved a new one-tablet 600mg. formulation in February 2002, of this non-nucleoside reverse transcriptase inhibitor used in combination treatment for HIV. The new formulation will provide doctors with the option of prescribing one 600mg. tablet once daily instead of three 200mg. capsules once daily.
|
|
Oral Contraceptive
|
Estradiol/Levonorgestrel
Alesse®
Wyeth-Ayerst Canada
|
TPP – Canada approved this birth control pill in January 2002, for the treatment of moderate acne in women.
|
|
Oncologic Agent
|
HSPPC-96
Oncophage®
Antigenics
|
The US FDA granted fast-track designation in February 2002, for this cancer vaccine for the treatment of metastatic melanoma.
|
|
HIV/AIDS
|
Tenofovir Disoproxil Fumerate
Viread®
Gilead Sciences
|
The EMEA granted marketing approval in all 15 member states of the European Union in February 2002, for use in combination with other antiretroviral agents for the treatment of HIV infection in patients who are experiencing early virological failure.
|
|
Antihistamine
|
Desloratidine
Clarinex® 5mg. Tablets
Schering-Plough
|
The US FDA approved additional indications for this antihistamine in February 2002, to treat chronic idiopathic urticaria and symptoms of allergies caused by indoor and outdoor allergens in adults and children >12 years of age.
|