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FDA Grants Accelerated Approval to New Melanoma Drug

It was recently reported that the FDA has granted accelerated approval for the melanoma drug Keytruba (pembrolizumab). The treatment is intended for patients with advanced or intractable melanoma who are no longer responding to other drugs. For patients with tumors exhibiting BRAF V600 gene mutations, Keytruba is indicated for use after impilimumab and a BRAF inhibitor.

FDA Requires Black Box Warning on Tanning Beds Nation-Wide

In order to inform and protect consumers from the risks of sunlamp products such as tanning beds, the FDA is changing the classification and requiring a black box warning to be clearly visible on each indoor tanning device. The warning will emphasize the heighten risk for those younger than 18 or for people with a family history of skin cancer, and include language advising regular skin cancer evaluations for persons repeatedly exposed to UV radiation. 

FDA Approves New Drug for Psoriatic Arthritis

In a statement released on March 21, 2014, the U.S Food and Drug Administration announced that the FDA approved a new drug to treat adults with active psoriatic arthritis (PsA). The new drug is “Otezla”, and Bill Berkot, in “Update 2- U.S.

FDA Approves New Drug for Tinea Corporis

The FDA recently approved a new drug application to treat tinea corporis, tinea cruris, and tinea pedis. The drug is luliconazole, a topical azole antifungal cream.

Luliconazole is approved for a 1-week, once-daily treatment regimen treatment course in adults over 18 years old with tinea corporis or tinea cruris. Treatment for interdigital tinea pedis is once daily for 2 weeks. 

Product Theater- Sponsored by Valeant - Imiquimod 5% cream - Dr. Batiav

This podcast is on the use of Imiquimod 5% cream with Dr. Batiav and was recorded at the 2013 Summer SDPA Conference in St. Louis.
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