The U.S Food and Drug Administration has issued a letter of approval regarding the New Drug Application for Adams Respitory Therapeutics Inc's (NASDAQ:ARXT) Mucinex with Codeine.
Mucinex with Codeine is to be used in the prescription treatment of cough associated with the common cold, inhaled irritants and stable chronic bronchitis.
The FDA stated that it had it had completed its review of the medication and that it was approvable however prekiminary labeling comments are required in addition to more data on the use of the product with food.
"An approvable letter for Mucinex with Codeine is a positive step in the FDA review process," said COO Robert D. Casale. "As a next step, we intend to seek a meeting with the agency in order to agree on an approach. We will then move as expeditiously as possible to fulfill the requirements
for final approval."
[Source: PRNewsWire]
Comment Preview