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