(Adds details, 2008 view)
Oct 29 Adams Respiratory Therapeutics Inc
ARXT.O said U.S. health regulators are seeking additional
data for the approval of Mucinex with codeine for the
prescription treatment of coughs related to colds, inhaled
irritants and chronic bronchitis.
The U.S. Food and Drug Administration issued an approvable
letter to the drug developer, a notice that specifies
conditions to be fulfilled before a product is approved.
In addition to some preliminary labeling comments, the FDA
requested additional data to support the use of the product
In May, the FDA asked companies to stop making and
distributing certain cough and cold medicines containing
guaifenesin, that are sold without the agency's approval.
Only Adams Respiratory's products -- Mucinex and Humibid --
had the FDA's approval.
Manufacturers have until Nov. 25 to stop shipping the
products that have not gone through the FDA's approvable
The company raised its fiscal 2008 net sales outlook based
on early customer response to the FDA enforcement action. Adams
said its early sales guidance did not include any potential
revenue from Mucinex with codeine.
Adams now expects its fiscal 2008 net sales to be at the
higher end of its previously view of $400 million to $440
It expects fiscal 2008 earnings per share to be at the
higher end or slightly exceed the previous outlook of $1.55 to
$1.75 a share.
Analysts on average expect Adams to earn $1.65 a share, and
post revenue of $416 million for fiscal 2008, according to
(Reporting by Jennifer Robin Raj in Bangalore)