Marksans Pharma has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Guaifenesin Extended-Release Tablets, 600 mg and 1200 mg (OTC).
The Guaifenesin Extended-Release Tablets, 600 mg and 1200 mg (OTC) are bioequivalent to the reference listed drug (RLD), Mucinex Extended-Release Tablets, 600 mg and 1200 mg, of RB Health (US) LLC.
Guaifenesin extended-release tablets help to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. The company expects to launch the product immediately.