The tentative approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) of Binimetinib tablets of strength 45 mg, Alembic Pharmaceuticals said in a regulatory filing.
Based on USFDA’s paragraph IV certifications list, Alembic is the sole first applicant to have filed its ANDA for Binimetinib Tablets, 45mg and upon final approval of this ANDA by the USFDA, the company may be eligible for 180 days of generic marketing exclusivity in the US, the company said.
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Alembic had previously received tentative approval for Binimetinib Tablets, 15mg, it added.
Binimetinib in combination with encorafenib is used for the treatment of patients with unresectable or metastatic melanoma with resistance to specific targeted therapies in cancer.
It is also indicated, in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with resistance to specific targeted therapies.Read More: India raises price cap on cancer drugs to tackle shortage
Citing IQVIA data, Alembic said Binimetinib tablets have an estimated market size of USD 259 million for 12 months ending March 2026.
