FDA approves first generic enoxaparin product
- Sandoz Beats Competition to Generic Hyperthyroid Drugs. Mirasol, Feliza // Chemical Market Reporter;7/5/2004, Vol. 266 Issue 1, p12
Reports on the approval of the U.S. Food and Drug Administration on the generic formulation of levothyroxine from Sandoz Inc. Use of the drug for treating hyperthyroidism; Denial of the administration on the move of Abbott Laboratories Inc. and King Pharmaceuticals Inc. to block the approval for...
- Growth hormone OK'd for adults and kids. Fernandez, Julio // Drug Topics;7/10/2006, Vol. 150 Issue 13, p20
The article reports on the approval of somatropin, marketed by U.S.-based generic pharmaceutical company Sandoz Inc. as Omnitrope, by the U.S. Food and Drug Administration (FDA). Omnitrope was approved by the FDA through the Food, Drug & Cosmetic Act, and was characterized as a follow-on protein...
- FDA Accepts Momenta/Sandoz ANDA for Generic Copaxone. Morrison, Trista // BioWorld Today;7/14/2008, Vol. 19 Issue 135, p1
The article announces that the U.S. Food and Drug Administration (FDA) has accepted the abbreviated new drug application for M356 of Momenta Pharmaceuticals Inc. and partner Sandoz Inc. The new drug application is a generic version of peptide-based multiple sclerosis drug Copaxone. Despite of...
- Omnitrope Is Given a New Indication. // Chain Drug Review;9/27/2010, Vol. 32 Issue 16, p60
The article reports on the approval of Sandoz Inc.'s Omnitrope drug as treatment of idiopathic short stature (ISS) by the U.S. Food and Drug Administration (FDA).
- News Briefs. // American Journal of Health-System Pharmacy;9/15/2010, Vol. 67 Issue 18, p1499
The article reports that the U.S. Food and Drug Administration (FDA) has approved a new formulation of docetaxel and a needleless intravenous (i.v.) connector with chlorhexidine and silver and zero-fluid displacement.
- Slew of approvables. // Drug Topics;11/17/2003, Vol. 147 Issue 22, p27
Lists several approval drugs by the U.S. Food and Drug Administration. Ranexa to treat chronic angina; Insulin determir, a long-acting form of the diabetes drug; Fortament, an extended-release product to lower blood glucose.
- FDA actions in brief. // Formulary;Feb2010, Vol. 45 Issue 2, p42
The article discusses news briefs about drugs approved by the U.S. Food and Drug Administration (FDA). The drugs include dalfampridine extended release tablets, tocilzumab and morphine sulfate oral solution.
- Pipeline preview. // Formulary;Apr2010, Vol. 45 Issue 4, p113
The article offers U.S. Food & Drug Administration (FDA) drug approval news briefs. Miglustat has been approved for the treatment of Niemann-Pick type C disease, pirfenidone has been recommended for approval to improve lung function and pixantrone has been recommended not to be approved.
- FDA actions in brief. // Formulary;Apr2010, Vol. 45 Issue 4, p114
The article presents a list of drugs approved by the U.S. Food & Drug Administration (FDA) including doxepin for the treatment of insomnia, adapalene lotion for the treatment of acne and somatropin injection for the treatment of growth hormone disorders.