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    New Products: BPH surgical robot granted FDA de novo request

     

     

    FDA approves new indication for renal cell carcinoma treatment

    The FDA has approved a new indication for sunitinib malate (SUTENT), expanding its use to include the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy. Pfizer said the approval was based on results from the S-TRAC trial that demonstrated a significant reduction in the risk of a disease-free survival event (defined as the interval between randomization and tumor recurrence, or secondary primary cancer or death from any cause) for patients at high risk of RCC recurrence who received SUTENT compared to placebo in the adjuvant setting. SUTENT had been previously approved for the treatment of advanced renal cell carcinoma. 

    For more information, visit www.pfizer.com.

    Generic versions of erectile dysfunction treatment launched

    Greenstone LLC and Teva Pharmaceutical Industries Ltd. are each launching generic versions of Viagra tablets (sildenafil citrate) in the U.S. Greenstone said its version of the erectile dysfunction drug will be available in strengths of 25 mg, 50 mg, and 100 mg. Teva said it is offering wraparound services to support patients, such as a sildenafil tablets savings card with which people who meet certain requirements are eligible to participate in the program and may pay as little as $0 out of pocket with a maximum benefit of up to $100 per fill, for up to six sildenafil tablets prescriptions. 

    For more information, visit www.greenstonellc.com and www.tevausa.com.


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