Biological E gets CDSCO Panel nod to manufacture, market FDC Chlorpheniramine Maleate,Noscapine Oral Liquids
New Delhi: Pharmaceutical major, Biological E has got a go-ahead from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) to manufacture and market the fixed dose combination (FDC) Chlorpheniramine Maleate 2mg/2mg plus Noscapine 15mg/7mg Oral Liquids.
This came after the firm presented Phase-III clinical trial (CT) report of the FDC Chlorpheniramine Maleate plus Noscapine Oral Liquids before the committee.
Chlorpheniramine is a histamine-H1 receptor antagonist indicated for the management of symptoms associated with upper respiratory allergies. Chlorpheniramine binds to the histamine H1 receptor. This blocks the action of endogenous histamine, which subsequently leads to temporary relief of the negative symptoms brought on by histamine.
Noscapine is a phthalide isoquinoline non-narcotic alkaloid derived from the opium poppy Papaver somniferum, with mild analgesic, antitussive, and potential antineoplastic activities. Noscapine is an antitussive (cough suppressants). It exerts its antitussive effects through the activation of sigma opioid receptors.
Last year, regarding the fixed dose combination (FDC) Chlorpheniramine Maleate plus Noscapine Oral Liquids, the expert panel noted that Chlorpheniramine is antihistaminic and Noscapine is cough suppressant and therefore its combination may be rational. In addition, the Committee had recommended that the firm conduct a randomised Phase III clinical trial before considering the grant of permission to manufacture and market the proposed FDC.
In line with the above recommendation, the firm presented Phase III clinical trial protocol before the committee and at 57th SEC meeting for Pulmonary held on 25.02.2022, the committee granted permission to conduct the proposed Phase III CT study of Chlorpheniramine Maleate 2mg/2mg plus Noscapine 15mg/7mg Oral Liquids.
In continuation, at the recent SEC meeting for Pulmonary held on September 29,2022, the expert panel reviewed the Phase-III CT report of the proposed FDC Chlorpheniramine Maleate 2mg/2mg plus Noscapine 15mg/7mg Oral Liquids presented by Biological E.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market the proposed FDC.
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