Sun Pharma receives USFDA approval for generic Strattera capsules
Sun Pharma, a speciality pharmaceuticals and active pharmaceutical ingredients maker, has recieved US Food and Drug Administration (USFDA) for its subsidiary an approval for its abbreviated new drug application to market a generic version of Strattera, Atomoxetine hydrochloride capsules.
These generic atomoxetine hydrochloride capsules are equivalent to Eli Lilly’s Strattera capsules and include six strengths: 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, and 100 mg.
Annual sale in U.S. for these strengths of branded and generic atomoxetine hydrochloride capsules is estimated at over $530 million.
Atomoxetine Hydrochloride capsules are used for the treatment of attention deficit hyperactivity disorder in children aged 6 and older, teens and adults.
The company receives 180 days marketing exclusivity for this drug.
The company manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.
In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastroenterology, orthopedics and ophthalmology.
The USFDA issued a warning letter to Sun Pharma for violations in current good manufacturing practice regulation at its Cranbury facility in New Jersey. USFDA has withheld approval of pending new drug applications listing the facility as the manufacturer, Sun Pharma said in a statement on Tuesday.
It has also recieved USFDA’s approval to a generic version of Venlafaxine Hydrochloride Extended Release tablets.
On Wednesday, the company's shares were down by 0.80 percent at 1,746.00 rupees.
Sep 07, 2010