New FDA Approvals
These drugs have received final approval from the Food and Drug Administration (FDA):
Mesalamine (Canasa) suppositories by Axcan Scandipharm Inc. Mesalamine has received approval for use in suppository form for the treatment of active ulcerative proctitis. The treating dose is 500 mg twice daily, but may be increased to 500 mg three times daily if there is an inadequate response after two weeks of therapy.
Antidepressant mirtazapine (Remeron SolTab) orally disintegrating tablet by Organon Inc. The FDA has granted approval for a new formulation of mirtazapine for relief of depression and its associated symptoms of anxiety, insomnia, and reduced appetite. Instead of having to be swallowed, this tablet dissolves on the tongue within 30 seconds.
Steroid prednisolone sodium phosphate (Orapred) oral solution by Ascent Pediatrics Inc. Orapred has received approval as a treatment for children with asthma and other inflammatory conditions. Each 5 mL of Orapred (prednisolone sodium phosphate 20.2 mg) is the equivalent of prednisolone 15 mg.
Tolterodine tartrate (Detrol) LA capsules by Pharmacia. The FDA has granted approval for the extended-release formulation of this agent for overactive bladder with symptoms of urinary urge incontinence, urgency, and frequency. Detrol LA is to be available in 2 mg and 4 mg capsules.
In the Pipeline
Alliance Pharmaceutical Corp. has voluntarily suspended enrollment in its Phase III study with its perflubron emulsion (Oxygent) due to an imbalance in adverse events, namely stroke.
Aronex Pharmaceuticals received a nonapproval letter from the FDA for tretinoin liposome for injection (Atragen) as treatment for patients with acute promyelocytic leukemia who require tretinoin but who require it in an IV form. As part of the letter, the FDA noted that the proposed claim was not supported because the data did not establish the existence of the patient population described in the claim.
Cellegy Pharmaceuticals Inc. has been granted patent protection by the Canadian Intellectual Property Office for compositions used in the treatment of anal disorders. This patent covers Cellegy’s nitroglycerin ointment (Anogesic) which is currently in Phase III clinical trials in the United States for treatment of anal fissures. Patents protecting this drug product now exist in the United States, Europe, Canada, and Singapore, and are pending in other countries.
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