CDSCO panel grants approval to Akums for PK study of pulmonary FDC
New Delhi: Citing that the pharmacokinetic study should be presented before the committee for review, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted approval to drug major Akum Pharmaceutical to conduct the pharmacokinetic (PK) study for the fixed-dose combination of the pulmonary drug, Levosalbutamol Sulphate plus Ambroxol Hydrochloride plus Guaiphenesin.
This came after the firm presented the PK study protocol of FDC Levosalbutamol Sulphate plus Ambroxol Hydrochloride plus Guaiphenesin before the committee.
Levosalbutamol Sulphate plus Ambroxol Hydrochloride plus Guaiphenesin belongs to the class of medicines called 'expectorants' primarily used to treat cough associated with mucus. Coughing (dry or productive) is the body's way of clearing irritants (like allergens, mucus, or smoke) from airways and preventing infection.
Levosalbutamol sulphate works by relaxing muscles and widening the airways of the lungs. Ambroxol hydrochloride is a mucolytic drug that thins and loosens phlegm (mucus) in the lungs, windpipe, and nose. It also thins and softens coughs and sputum, facilitating simple coughing out as a result. Guaiphenesin works by increasing the volume of fluid in the airways, reducing the stickiness of mucus, and helping to remove it from the airways.
At the recent SEC meeting for Pulmonary held on 21st March 2023, the expert panel reviewed the PK study protocol of the FDC drug Levosalbutamol Sulphate plus Ambroxol Hydrochloride plus Guaiphenesin Oral drops
After detailed deliberation, the committee recommended for conducting the PK study.
Furthermore, the expert panel directed that the result of the study should be presented before the committee for review.
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