Micro Lab Gets CDSCO panel Nod To Manufacture and Market Ebastine plus Phenylephrine FDC
New Delhi: Micro Labs has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the pulmonary fixed-dose combination (FDC) Ebastine plus Phenylephrine Hydrochloride Tablet.
This came after the firm presented its proposal and the bioequivalence (BE) report before the committee. The committee noted that CDSCO has already issued NOC for the proposed fixed-dose combination (FDC) on 04.01.2022 under an 18-month policy decision.
Ebastine plus Phenylephrine is used in the treatment of sneezing and runny nose due to allergies.
Ebastine belongs to the class of antihistamines (anti-allergic drugs) that work by blocking the action of histamine, a substance responsible for causing allergic reactions. It helps relieve allergy symptoms such as sneezing, running nose, watery eyes, itching, swelling, congestion, or stiffness.
Ebastine is used in the treatment of allergic conditions. Ebastine is an antihistaminic medication. It treats allergy symptoms such as itching, swelling, and rashes by blocking the effects of a chemical messenger (histamine) in the body. Your doctor has prescribed Ebastine to help relieve allergy symptoms such as itching, swelling, and rashes.
Phenylephrine is a medication used as a decongestant for uncomplicated nasal congestion, used to dilate the pupil, used to increase blood pressure (given intravenously in cases of low blood pressure), and used to relieve hemorrhoids. It can be taken by mouth, as a nasal spray, given by injection into a vein or muscle, or applied to the skin.
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery.
At the recent SEC meeting for Pulmonary held on 4th January 2024, the expert panel reviewed the proposal and the BE report of the FDC Ebastine plus Phenylephrine Hydrochloride Tablet.
The committee noted that CDSCO has already issued NOC for the proposed fixed-dose combination (FDC) on 04.01.2022 under an 18-month policy decision.
After detailed deliberation, the committee recommended granting permission for the manufacturing and marketing of the FDC.
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