(Adds details, 2008 view)
Oct 29 (Reuters) - 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 with food.
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 process.
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 million.
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 Reuters Estimates. (Reporting by Jennifer Robin Raj in Bangalore)