Hyderabad: Granules India Limited announced on Friday that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Guaifenesin and Pseudoephedrine Hydrochloride Extended-Release (ER) Tablets, 600 mg/60 mg and 1200 mg/120 mg (OTC).
It is bioequivalent to the reference listed drug product, Mucinex D Extended-Release Tablets, 600 mg/60 mg, and 1200 mg/120 mg, of RB Health (US) LLC.
Guaifenesin and Pseudoephedrine Hydrochloride ER Tablets are used to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive; temporarily relieve nasal congestion due to common cold, hay fever, upper respiratory allergies; temporarily restores freer breathing through the nose, promotes nasal and/or sinus drainage; and temporarily relieves sinus congestion and pressure, a company release said.
Granules now have a total of 51 ANDA approvals from the US FDA (49 Final approvals and 2 tentative approvals).
The Mucinex D brand and store brands had combined U.S. sales of approximately USD 71 million MAT for the most recent twelve months, the release added.
