New FDA Approvals
New FDA Approvals
These drugs recently received final approval from the Food and Drug Administration (FDA):
• Levothyroxine sodium (Levo-T) by Mova Pharmaceutical. Levothyroxine sodium (Levo-T) has been approved by the FDA for the treatment of hypothyroidism and the suppression of thyroid-stimulating hormone. Levothyroxine sodium will be available in dosages ranging from 25 mcg to 300 mcg.
• New indication for pantoprazole sodium (Protonix) delayed release tablets by Wyeth Pharmaceuticals. Pantoprazole sodium (Protonix) has been approved for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome. It was originally approved in February 2000 for the short-term treatment (up to eight weeks) and symptomatic relief of erosive esophagitis (EE) associated with gastroesophageal reflux disease (GERD). In June 2001 it was approved for the maintenance of healing of EE and daytime and nighttime control of heartburn associated with GERD.
• New indication for the estrogen replacement therapy system (Alora) by Watson Pharmaceuticals. The estrogen replacement therapy system (Alora) has been approved for the prevention of postmenopausal osteoporosis. In 1996, the system was approved for the treatment of moderate-to-severe vasomotor menopausal symptoms, specifically hot flashes.
• Secretin by Chesapeake Biological Laboratories. The FDA has approved secretin (Secreflo) for injection for use as an aid in confirming the diagnosis of pancreatic dysfunction and the presence of a pancreatic tumor (gastrinoma) that may become cancerous. Secretin is the first of its kind to receive FDA approval.
• New indication for rofecoxib (Vioxx) by Merck & Co. FDA has approved a supplemental application for the use of rofecoxib (Vioxx) for rheumatoid arthritis. Rofecoxib previously has been approved for osteoarthritis and pain. FDA also has approved new label text and precautions that are based on the results of the Vioxx Gastrointestinal Outcomes Research (VIGOR) study.
• Fulvestrant (Faslodex) Injection by AstraZeneca. FDA has approved the breast cancer drug fulvestrant (Faslodex) Injection for treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy, such as tamoxifen. Fulvestrant is an estrogen receptor antagonist without known agonist effects. It is the only estrogen receptor antagonist to be proven effective after tamoxifen failure.
• The angiotensin II receptor blocker (ARB) Benicar by Sankyo Pharma. The FDA has granted marketing approval for the angiotensin II receptor blocker (ARB) olmesartan medoxomil (Benicar), a new treatment option for hypertension. Benicar, which can be administered alone or in combination therapy with other antihypertensive agents.
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