[Ip-health] Sun Pharma gets tentative FDA nod for generic Gleevec tablets

[Joana Ramos]

http://www.business-standard.com/india/news/sun-pharma-gets-tentative-fda-nod-for-generic-gleevec-tablets/78491/on


> Sun Pharma gets tentative FDA nod for generic Gleevec tablets
> Press Trust of India / Mumbai November 17, 2009, 11:33 IST
>
> Sun Pharmaceutical Industries today said it has got tentative approval
> from the US drug regulator for generic Gleevec (imatinib meyslate
> tablets), used in the treatment of chronic myeloid leukaemia.
>
>
> The US Food and Drug Administration (USFDA) has granted tentative
> approval for the company's abbreviated new drug application (ANDA) for
> generic Gleevec, Sun Pharma said in a filing to the Bombay Stock
> Exchange (BSE).
>
> The tentatively approved drug (imatinib meyslate tablets) is
> therapeutically equivalent to Gleevec tablets of Novartis.
> The approval of imatinib mesylate tablets are in the strengths of 100
> mg and 400 mg.
>
> The annual sales of these tablets are about 950 million dollars in the US.
> Shares of Sun Pharmaceutical were trading at Rs 1,451.90, down 1.74
> per cent in the morning trade on the BSE.


and from the FDA website:

Drugs > News & Events

http://www.fda.gov/Drugs/NewsEvents/ucm130961.htm

See entry for Nov. 16, 2009 under

New and Generic Drug Approvals

> Imatinib Mesylate Tablets, Sun Pharmaceutical Industries Ltd.,
> Tentative Approval

which links to the following page:

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails




------------------
Joana Ramos, MSW
Cancer Resources & Advocacy
Seattle WA USA
+1-206-229-2420
http://ramoslink.info/
www.bmtbasics.org