Alembic Pharmaceuticals, Inc. announced the launch of fluphenazine hydrochloride
tablets, 1mg, 2.5mg, 5mg and 10mg.
Alembic’s fluphenazine hydrochloride tablets 1mg, 2.5mg, 5mg and 10mg have been determined to be bioequivalent and therapeutically equivalent to the reference listed drug, prolixin tablets, 1mg, 2.5mg, 5mg and 10mg, of Apothecon Inc. (Apothecon). Fluphenazine hydrochloride tablets are are indicated in the management of manifestations of psychotic disorders.
[Read more: Alembic gets FDA tentative OK for generic Bosulif]
Fluphenazine hydrochloride is not approved for the treatment of patients with dementia-
related psychosis.
Alembic will offer the tablets in strengths of 1mg, 2.5mg, 5mg and 10mg, in 100-ct bottles. This marks Alembic USA’s 158 th product launch since commencement of U.S. operations in October 2015.