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Approvals from the US FDA

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  • 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 fol-lowed 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 hyper-ammonaemia 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 Sheet-Prescription 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