Cadila Healthcare gets CDSCO panel okay for Fluticasone Furoate, Oxymetazoline HCL nasal spray
New Delhi: In a major rejoice for pharma major Cadila Healthcare, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has given its nod to manufacture and market the Fixed Dose Combination (FDC) drug Fluticasone Furoate plus Oxymetazoline Hydrochloride IP (27.5mcg + 50mcg) Nasal spray.
This came after the drug maker Cadila Healthcare presented a Phase-III Clinical Trial report before the committee at the 52nd SEC meeting for Pulmonary, held on 07.07.2021 at CDSCO.
Fluticasone furoate is a synthetic glucocorticoid available as an inhaler and nasal spray for various inflammatory indications. It can be used as maintenance treatment of asthma and/or chronic obstructive pulmonary disease (COPD) depending on the product. Further, Fluticasone furoate, available as a nasal spray, is used to manage symptoms of allergic rhinitis. Fluticasone furoate was first approved in 2007.
Oxymetazoline hydrochloride is a vasoconstrictor that is used to relieve nasal congestion. Oxymetazoline binds to and activates alpha-2 adrenergic receptors. Upon nasal or ocular administration, oxymetazoline constricts the arterioles in the nose and eye, resulting in decreased nasal and conjunctival congestion, respectively.
The Phase-III Clinical Trial data of proposed fixed dosage combination medication Fluticasone Furoate with Oxymetazoline Hydrochloride IP (27.5mcg + 50mcg) Nasal spray was thoroughly examined by the committee at the 52nd SEC meeting for Pulmonary.
Responding to the presented data, after detailed deliberation, the committee recommended grant of permission to manufacture and market the proposed FDC, Fluticasone Furoate plus Oxymetazoline Hydrochloride IP (27.5mcg + 50mcg) Nasal spray.