Sun Pharmaceutical Industry gets CDSCO Panel nod to study Fexuprazan HCL tablet for erosive esophagitis
New Delhi: Responding to the proposal presented by the Sun Pharmaceutical Industry to manufacture and market the Fexuprazan Hydrochloride tablet, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the firm for conducting the bioequivalence study of the proposed drug.
This came after Sun Pharmaceutical Industry presented their proposal for a grant of permission to manufacture and market Fexuprazan Hydrochloride tablets, 40 mg, indicated for the treatment of erosive esophagitis (EE) along with the bioequivalence study protocol vide protocol No. 052/23 Version-00, Dated: 22.01.2024, before the committee.
Erosive esophagitis (EE) is an erosion of the esophageal epithelium due to chronic irritation. It can be caused by a number of factors but is primarily a result of gastroesophageal reflux disease (GERD). The main symptoms of EE are heartburn and regurgitation; other symptoms can include epigastric pain, odynophagia, dysphagia, nausea, chronic cough, dental erosion, laryngitis, and asthma. Symptoms can be exacerbated by eating certain trigger foods or when lying down.
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