Alembic Pharmaceuticals Ltd says it has received tentative approval from the US Food and Drug Administration (USFDA) for its generic version of binimetinib tablets. In a regulatory filing, the company states the tentative approval applies to its Abbreviated New Drug Application (ANDA) for binimetinib tablets in the 45 mg strength. One outlet reports that, based on USFDA’s paragraph IV certifications list, Alembic is the sole first applicant that has filed an ANDA for the 45 mg product. The company adds that, if the ANDA receives final approval, it may be eligible for 180 days of generic marketing exclusivity in the US. The reports also note that Alembic had previously received tentative approval for binimetinib tablets in the 15 mg strength. Binimetinib is used in combination with encorafenib for treatment of certain cancers, including unresectable or metastatic melanoma with resistance to specific targeted therapies and metastatic non-small cell lung cancer (NSCLC) with resistance to specific targeted therapies. Alembic cites IQVIA data estimating a market size of about USD 259 million for the 12 months ending March 2026.