22 MARKET NEWS Approvals from the US FDA
Lilly's nucleoside analogue gemcitabine ['Gemzar'] has been approved in the US for the first-line treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. 1
Gemcitabine can also be used in patients who have previously been treated with fluorouracil.
It is recommended that gemcitabine is administered as an IV dose of 1000 mg/m2 infused over 30 minutes. 1 For the first treatment cycle, this dose should be given once weekly for up to 7 weeks followed by a I-week rest period. For subsequent cycles, gemcitabine should be given for 3 consecutive weeks followed by a I-week rest period. It is estimated that each treatment cycle will cost $USI375.2
Gemcitabine has been approved in 7 other countries for the treatment of pancreatic cancer, and in 17 countries for the treatment of other cancers, including non-small-cell lung cancer. 1,2
Sodium phenylbutyrate ['Buphenyl'; Ucyclyd Pharma] in tablet and powder formulations has been approved for marketing by the FDA.31t is an orphan drug that is indicated for the treatment of hyperammonaemia in patients with urea cycle disorders.
The antifungal agent terbinmme ['Lamisil'; Sandoz] has been approved in the US for the oral treatment of fungal nail infections (onychomycosis).4 1. lilly Gemzarforpancreatic cancer to be priced at 51,375 per treatment cycle; gemcitabine under study for non-small ceUlung cancer. FDe Reports - Pink SheetPrescription Phannaceuticals and Biotechnology 58: 6-7, 20 May 1996 2. lilly's Gemzar approved in US. Scrip: 20, No. 2131, 24 May 1996 3. FDA approves Buphenyl for urea cycle disorders. Scrip: 23, No. 2131, 24 May 1996 4. Product news in brief: Sandoz' oral antifungal Lamisil (tezbinafine) .•. Marketletter 23: 22, 20 May 1996 800431128
Inpharma8 1 Jun 1996 No. 1039 0156-270319611039-000221$01.00° Ad!s International Limited 1996. All rights reserved