New FDA Approvals
July 1, 1999 2 minutes read
New FDA Approvals
These drugs and/or new indications have received final approval from the U.S. Food and Drug Administration:
AIDS-related Kaposi’s sarcoma cutaneous lesion treatment Panretin (alitretinoin 0.1%) by Ligand Pharmaceuticals. Approval for topical gel, which activates retinoid receptors to regulate gene expression of cell proliferation, follows clinical trials in which 35% of 268 patients experienced partial response in 12 weeks; results were matched in subsequent trials. Average response time was four to eight weeks. Redness, skin irritation, pruritus, edema were common reactions. Twice daily application is recommended regimen; can be increased up to four times daily if well-tolerated. Supplied in 60 g tubes. Contra indic ated in patients requiring systemic Kaposi’s therapy and for treatment of visceral lesions. Menopause treatment Cenestin A (synthetic conjugated estrogens) by Duramed Pharmaceu ticals. Chemically derived plant compound indicated for treatment of moderate to severe vasomotor symptoms associated with menopause; is product of nine estrogenic components. Approval follows 12-week placebo-controlled, randomized trial of 120 patients who experienced reduced symptoms, with majority receiving 1.25 mg daily. Supplied in 0.625 mg and 0.9 mg tablets; the former is recommended initial dose that can be increased to 1.25 mg. Expanded indication for the selective serotonin reuptake inhibitor Paxil (paroxetine HC1) by Smith Kline Beecham. Approved for depression, panic disorder, obsessive compulsive disorder, new approval is first for social anxiety disorder, though many diagnoses overlap. In placebo-controlled 12-week trial at 20 mg to 50 mg daily, response rates were 69% of Paxil group vs. 29% of placebo. Common side effects: sweating, nausea, dry mouth, constipation, decreased appetite, somnolence, tremor, and decreased libido in men and women. Hepatitis C home testing kit Hepatitis C Check by Home Access Health. Hepatitis C antibodies test kit includes fingerstick lancet and contact paper to be mailed to company for lab processing, evaluation, response, counseling, or referrals. Approval follows earlier marketing of similar HIV home testing product. Details on telemedicine company and its home care products can be found at homeaccess.com or (888) 888-HEPC. Bronchospasm maintenance treatment Ipratropium Bromide Inhalation Solution 0.02% by Alpharma as the generic equivalent to Boeh ringer’s Ingleheim’s Atroventa. Specifically indicated for bronchospasm associated with chronic obstructive pulmonary disease including bronchitis and emphysema and available in five 2.5 ml vials.Article Limit Reached
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