The drug is approved for the treatment in metastatic colorectal carcinoma, metastatic breast cancer and ovarian, cervical and renal cancer
In some countries such as France, Italy, Spain and the Balkan region, Menarini Group will lead the commercialisation effort, as part of an exclusive licensing agreement signed with Glenmark
The company will review FDA's response and decide on appropriate next steps soon.
Granules now has a total of 37 ANDA approvals from US FDA (36 Final approvals and 1 tentative approvals).
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