According to Sun Pharmaceutical Industries Ltd the USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) for marketing of atomoxetine hydrochloride capsules, the generic version of Strattera.
These generic capsules are equivalent to Eli Lilly's Strattera capsules and come in six strengths: 10mg, 18mg, 25mg, 40mg, 60mg, and 100mg.
US annual sales of branded and generic atomoxetine hydrochloride capsules of the six strengths is estimated at over $530 million.
Atomoxetine hydrochloride capsules are indicated in attention deficit hyperactivity disorder in children aged six and older, and also in teens and adults.
In another development the company has been issued a warning by the USFDA for manufacturing practice violations at its Cranbury facility in New Jersey. The regulator has withheld the approval process for its new drug applications listing the facility as the manufacturer according to the company's statement.
The decision, though is not likely to hurt the company's US operations much as the Cranbury plant manufactures only a limited range of products, mainly four or five controlled substance drugs or drugs included in the narcotics category and according to a Sun Pharma spokesperson the revenue impact is expected to be only in 'single-digit million dollars.'
Meanwhile, Sun Pharma continued its 2010-11 consolidated sales growth projection of 18-20 per cent over the reported sales of 2009-10.
According to analysts though the USFDA decision may not have much impact on Sun Pharma in terms of revenue, the sentiment associated with a warning letter may pull down stocks in the context of developments at Caraco.