Aurobindo receives FDA OK for 2 generics

Aurobindo has gained the Food and Drug Administration’s permission for two generics.

Aurobindo has approval for fluphenazine hydrochloride tablets in dosage strengths of 1 mg, 2.5 mg, 5 mg and 10 mg.

The medication, which is the generic of Apothecon’s Prolixin, is indicated for the management of manifestations of psychotic disorders.

[Read more: Aurobindo receives FDA approval for 3 generics]

Fluphenazine Hydrochloride tablets have an estimated market value of $24 million for the 12 months ending June 2023, per IQVIA.

Aurobindo also has received the FDA's nod for Loperamide Hydrochloride capsules, 2 mg, which is the generic of Imodium, manufactured by Johnson and Johnson Consumer, McNeil Consumer Healthcare division.

Loperamide Hydrochloride Capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. They also are indicated for reducing the volume of discharge from ileostomies. 

[Read more: Aurobindo receives FDA approval for 3 generics]

Loperamide Hydrochloride Capsules have an estimated market size of $21.8 million for the 12 months ending June 2023, per IQVIA.