Approvals (FDA, Total)
12-30-2008 |
08:04 hs.
Allergan Inc. was cleared by the Food and Drug Administration to market Latisse, a solution to treat Hypotrichosis, the first drug to make eyelashes longer, darker and thicker. The main compound is the same a Lumigan, to treat glaucoma since 2001.
12-23-2008 |
12:22 hs.
Epix Pharmaceuticals Inc. announced that the Food and Drug Administration authorized marketing for the first blood pool magnetic resonance angiography (MRA) agent Vasovist (gadofosveset trisodium) in the U.S. Vasovist has been approved to be used outside of the US.
12-16-2008 |
10:24 hs.
Genzyme Corp., one of the world’s leading biotechnology companies, announced that the Food and Drug Administration, granted marketing approval for Mozobil drug, indicated for stem cell transplantation in patients with the blood cancers non-Hodgkin´s lymphoma and multiple myeloma.
Antihemophilic Factor VIII (Recombinant)
10-14-2008 |
11:30 hs.
Bayer HealthCare LLC announced that the U.S. Food and Drug Administration (FDA) has approved routine prophylaxis with Kogenate FS (antihemophilic factor VIII recombinant) to reduce the frequency of bleeding episodes and the risk of joint damage in patients aged 0-16 years with severe hemophilia A with no pre-existing joint damage.
10-08-2008 |
10:17 hs.
Viread
08-12-2008 |
09:03 hs.
Gilead Sciences announced the Food and Drug Administration (FDA) has granted its approval to market their AIDS drug Viread (tenofovir) for treating adults with chronic hepatitis B. Viread joins Gilead´s Hepsera as a hepatitis B treatment.
06-23-2008 |
13:17 hs.
The FDA has licensed pediatric vaccine Pentacel for use in infants 6 weeks through 4 years of age for active immunization against Haemophilus influenzae type b bacteria, according to Sanofi Pasteur, the Sanofi-Aventis Group vaccines division. Pentacel is the first vaccine of its type to be cleared in the U.S.
Bowel Drug
04-22-2008 |
17:13 hs.
Drug to treat opioid-induced constipation
04-01-2008 |
13:00 hs.
Wyeth and Progenics said Wyeth received marketing approval from the Canadian regulatory agency, Health Canada, for constipation treatment Relistor (methylnaltrexone bromide injection) for subcutaneous use. Health Canada’s decision is the first regulatory approval of this novel medication anywhere in the world
03-16-2008 |
21:00 hs.
Jazz & Solvay
03-03-2008 |
14:30 hs.
Belgian drugmaker Solvay and U.S. Jazz Pharmaceuticals said the FDA approved once-a-day Luvox extended-release formulation for the treatment of social anxiety disorder (SAD) and obsessive-compulsive disorder (OCD) in adults
Droga para la esclerosis múltiple de Biogen Idec y Elan Corp
02-08-2008 |
11:02 hs.
Tres médicos informaron mediante una carta enviada a la New England Journal of Medicine la aparición de dos casos de melanomas en mujeres que se encontraban en tratamiento con la droga para la esclerosis múltiple Tysabri. La droga, muy controvertida, fue originalmente aprobada en noviembre del 2004, retirada del mercado en febrero del 2005 luego de que se detectaran tres casos de leucoencefalopatía multifocal progresiva y vuelta a aprobar a mediados del 2006, bajo un estricto programa de control.


