Alembic Pharmaceuticals receives tentative FDA approval for generic binimetinib 45-mg
Business
Alembic Pharmaceuticals just scored a tentative green light from the US Food and Drug Administration for its generic binimetinib tablets (45-mg).
This medicine, used alongside encorafenib, helps treat tough cases of melanoma and lung cancer when other targeted therapies stop working.
It's a pretty big deal for patients needing more options.
Alembic could win 180-day US exclusivity
Alembic is the first to file for this version in the US which could land them 180 days of exclusive sales if they get final approval.
With both 15-mg and 45-mg strengths covered, they're set to tap into a $259 million market for the 12 months ending March 2026—definitely a big win for the company.