Tuesday, January 08, 2008

First-Time Generic Approvals: Arava, Renova, Retrovir.

Oct. 21, 2005 — The U.S.
Food and Drug Term of office (FDA) has approved first-time vino
formulations of leflunomide 10- and 20-mg tablets for the intervention
of person rheumatoid arthritis; 0.05% tretinoin emollient dairy product
for adjunctive use on skin care skin to palliate fine wrinkles, mottled
hyperpigmentation, and tactile roughness; and zidovudine 50-mg/5-mL
oral answer and 300-mg tablets for use in compounding with other
antiretroviral agents in the idiom of HIV illegality.
On
Sept. 13, the FDA approved first-time wine formulations of leflunomide
10- and 20-mg tablets (made by Barr Laboratories, Inc.; name name
Arava, made by Aventis Pharmaceuticals, Inc.).

Leflunomide
tablets are indicated to reduce signs and symptoms, inhibit structural
casualty as evidenced by x-ray erosions and coffin nail grapheme
decrement, and improve physical part in adults with individual
rheumatoid arthritis.
On Sept. 15, the FDA approved a first-time
ware preparation of 0.05% tretinoin emollient toiletry (made by
Implement Pharmaceuticals; kind name Renova, made by Ortho-McNeil
Pharmaceuticals, Inc.).

Tretinoin emollient pick 0.05% is
indicated as an adjunctive factor for use in the mitigation/palliation
of fine wrinkles, mottled hyperpigmentation, and tactile choppiness of
skin care skin in patients who do not achieve such easing using
comprehensive skin care and sun avoidance programs alone.

On
Sept. 19, the FDA approved a first-time vino conceptualization of
zidovudine 50-mg/5-mL oral mixture (made by Aurobindo Pharma Ltd.;
weapon name, Retrovir syrup, made by GlaxoSmithKline).

First-time
wine formulations of zidovudine 300-mg tablets (made by Aurobindo
Pharma Ltd., Roxane Laboratories, Inc., and Ranbaxy Laboratories Ltd.;
marque name Retrovir, made by GlaxoSmithKline) were also approved.

Zidovudine
tablets and oral answer are indicated for use in social unit with other
antiretroviral agents in the idiom of HIV incident.
This is a part of article First-Time Generic Approvals: Arava, Renova, Retrovir. Taken from "Arava Information" Information Blog

No comments: