India’s Sun Pharma has been awarded tentative approval from the US Food and Drug Administration for its generic Strattera capsules to treat attention deficit hyperactivity disorder (ADHD).
Sun Pharma’s atomoxetine hydrochloride capsules are therapeutically equivalent to Strattera capsules, produced in 10mg, 18mg, 25mg, 40mg, 60mg, 80mg and 100mg strengths by Eli Lilly.
Atomoxetine hydrochloride capsules have annual sales of about $500m in the US.