Skip to content

Aurobindo gets FDA approval for aripiprazole oral solution

EAST WINDSOR, N.J. – Aurobindo Pharma has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for aripiprazole oral solution, 1 mg/mL.

Table of Contents

EAST WINDSOR, N.J. – Aurobindo Pharma has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for aripiprazole oral solution, 1 mg/mL. Aurobindo’s aripiprazole oral solution is an AB-rated generic equivalent to the reference listed drug, Otsuka’s Abilify Oral Solution.

Aripiprazole oral solution is indicated for the treatment of:

  • Schizophrenia
  • Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder

Aurobindo’s aripiprazole oral solution has an estimated market size of $20M for the twelve months ending December 2018 according to IMS.

Comments

Latest