New FDA Approvals
August 1, 2000
New FDA Approvals
These drugs have received final approval from the U.S. Food and Drug Administration:
- Acne agent Differin (adapalene) Cream, 0.1% by Galderma Laboratories. Differin is indicated for topical treatment of acne vulgaris. It is to be applied to affected areas of the skin once daily, at nighttime, and is supplied in 15 and 45 gram tubes.
- Gonal-F (follitropin alfa) Injection by Serono Laboratories. Gonal-F has received FDA approval for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.
- Lipid-lowering agent Welchol (colesevelam hydrochloride) by GelTex Pharmaceuticals. Welchol, whether administered alone or in combination with an HMG-CoA reductase inhibitor, is indicated as adjunctive therapy to diet and exercise for reduction of elevated LDL cholesterol in patients with primary hypercholesterolemia (Fredrickson Type IIa).
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