FDA Approves New Plant-Derived Estrogen
The U.S. Food and Drug Administration has approved Cenestin in the 1.25 mg dosage strength, by Duramed Pharmaceuticals.

Cenestin is a plant-derived, synthetic conjugated estrogen product for the treatment of moderate to severe vasomotor symptoms associated with menopause. The FDA approved the 0.625 mg and 0.9 mg dosage strengths in 1999.

The addition of the 1.25 mg strength tablet provides clinicians with more dosing flexibility, according to a company press release.

Duramed successfully completed clinical trials in 1999 that showed that one 1.25 mg tablet of Cenestin was the bioequivalent of two of the 0.625 mg tablets.

FDA Committee Recommends Approval Cancer Drug
The U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) has unanimously recommended approval of Camptosar (irinotecan HCl injection) by Pharmacia & Upjohn as first-line therapy for the treatment of metastatic colorectal cancer in conjunction with fluorouracil and leucovorin.

Camptosar is being considered for approval based on survival data from two studies that demonstrate its potential in extending patients' lives when used as first-line therapy, according to a company press release.

ODAC made its unanimous recommendation for approval after examining data from two well-controlled phase III clinical trials. Study results suggest significant improvements in objective tumor response rates, time to tumor progression and prolongation of survival for the regimen of Camptosar with fluorouracil and leucovorin compared with fluorouracil and leucovorin alone. Data also showed that the addition of Camptosar to the other two drugs did not compromise prespecified quality of life indicators.

Camptosar, which received full FDA approval as second-line treatment for metastatic colorectal cancer in 1998, is also being studied as an adjuvant treatment option for earlier-stage colorectal cancer and is in clinical development for the treatment of other cancers such as lung and pancreatic cancers.

Topical Therapy Approved for Nail Fungus
Penlac Nail Lacquer Topical Solution 8% is now available from Dermik Laboratories Inc. for the treatment of toenail and fingernail fungus.

Penlac contains the active ingredient ciclopirox, a broad-spectrum antifungal agent that inhibits the growth of dermatophytes on the nails. Penlac was developed to provide safe, effective and convenient topical therapy for onychomycosis without systemic side effects, according to a company press release. Onychomycosis may affect as much as 12% of the general population in the United States-up to 50% in older populations, according to the company.

The approval of Penlac as the first prescription topical therapy for toenail and fingernail fungus in the United States opens up treatment for people who can't or don't wish to take oral medications for the condition, the company said. Penlac's advantage is that it penetrates the nail and targets the actual site of infection without the risk of drug interactions or systemic side effects.

Penlac is applied once daily with a brush to all affected nails and immediately adjacent skin for up to 48 weeks.