CDSCO panel grants approval to Akums for PK study of pulmonary FDC

Published On 2023-04-10 12:30 GMT | Update On 2023-04-10 12:30 GMT

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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Dr. Divya Colin

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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CDSCO panel grants approval to Akums for PK study of pulmonary FDC

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