CDSCO panel asks Cipla to include more Govt sites in Budesonide, Formoterol FDC study
New Delhi: Recommending to include more government sites, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has given its nod to pharmaceutical major Cipla to conduct a study of Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation.
The committee, however, has directed the firm to include more government sites, which should be geographically distributed throughout the country.
This approval came after the drug maker Cipla presented a bioequivalence (BE) study protocol before the committee.
In pharmacokinetics, bioequivalence refers to the expected in vivo biological equivalency of two proprietary pharmacological formulations. When two products are claimed to be bioequivalent, it signifies that they are expected to be identical in every way.
Budesonide/formoterol is a Fixed Dose Combination (FDC) drug that is used to treat asthma and chronic obstructive pulmonary disease (COPD). Budesonide is a corticosteroid used to treat Crohn's disease, asthma, COPD, hay fever and allergies, and ulcerative colitis. Formoterol is an inhaled long-acting beta2-adrenergic receptor agonist used as a bronchodilator in the management of asthma and COPD.
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