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These drugs recently received final approval from the Food and Drug Administration (FDA):
• Somatropin [rDNA origin] for injection (Genotropin) by Pharmacia. The FDA has approved Genotropin for the long-term treatment of growth failure in children who were born small for gestational age (SGA). The drug is indicated for children who do not achieve catch-up growth by age 2.
Since August 1995, Genotropin Lyophilized Powder has been approved for the long-term treatment of growth failure in children due to growth hormone deficiency (GHD). The drug also currently is marketed as replacement therapy in adults with a confirmed diagnosis of GHD of either childhood or adult onset. More recently, Genotropin was approved for the treatment of pediatric patients with Prader-Willi Syndrome, a genetically based developmental disability.
• Levothyroxine sodium tablets (Levoxyl) by Jones Pharma. Levoxyl been approved for use as a replacement therapy for any form of diminished or absent thyroid function and as a means of suppressing pituitary secretion of thyroid-stimulating hormone in euthyroid patients to treat or prevent goiters. Levoxyl is available in tablet formulation in 12 different color-coded strengths.
Levoxyl has been prescribed as a thyroid replacement therapy for 13 years. Due to a 1997 FDA ruling, all firms manufacturing levothyroxine sodium drugs were required to submit new drug applications to continue marketing these products.
• Ribavirin (Rebetol) by Schering-Plough. Rebetol capsules have been approved as a separately marketed product for use in combination with Intron A (interferon alfa-2b) injection. This drug is designed as a treatment for chronic hepatitis C in patients with compensated liver disease who have not had previous alpha interferon therapy or who have relapsed following successful therapy.
Rebetol has been approved in the United States since 1998 as part of a single-package combination therapy (known as Rebetron) that includes Rebetol capsules and Intron A injection. The new stand-alone package of Rebetol capsules provides patients and physicians with the option of individualized ribavirin and interferon-based therapies.
• Twinrix by GlaxoSmithKline. Twinrix is a combination hepatitis vaccine approved for the prevention of hepatitis A and B in adults 18 years and older. Populations likely to benefit from this new vaccine include chronic liver disease patients and health care personnel.