Sun Pharmaceutical gets tentative approval from USFDA for ‘Gleevec’
Submitted by Shilpa Mahapatre on Tue, 11/17/2009 - 16:59.
Sun Pharmaceutical Industries has received tentative authorization from USFDA for ANDA for generic Gleevec imatinib meyslate tablets.
The official permission has been granted for the pills in the strength of 100 mg and 400 mg. Gleevec imatinib meyslate tablets are the therapeutical variants of Novartis's Gleevec tablets.
The approved drug is indicated for treating chronic myeloid leukaemia. The yearly sales figure for Gleevec imatinib meyslate tablets is approximately USD 950 million in the United States.
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