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  • Justify Clinical...

Justify Clinical Relevance of Higher Strength of Caroverine Capsules: CDSCO Panel Tells Lincoln Pharma

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-01-01T17:30:54+05:30  |  Updated On 22 March 2024 10:39 PM IST
Justify Clinical Relevance of  Higher Strength of Caroverine Capsules: CDSCO Panel Tells Lincoln Pharma
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New Delhi: Noting that proposed higher strength of Caroverine Capsules (40mg) is not approved anywhere in the world, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined Lincoln Pharmaceuticals to submit therapeutic justification and clinical relevance of higher strength Caroverine Capsules 40mg along with Phase-III clinical trials protocol.

This came after Lincoln Pharmaceuticals presented the bioequivalence (BE) study report of Caroverine Capsules 40mg (additional strength) with a request for clinical trial (CT) waiver.

Caroverine belongs to the class 'antispasmodics', which is used for the treatment of smooth muscle spasms and tinnitus. It works by blocking the action of a chemical messenger in the brain (glutamate), thereby reducing the severity of tinnitus. It also acts as a smooth muscle relaxant with calcium-channel blocking properties used in conditions associated with painful smooth muscle spasms. CAROVERINE can be taken with or without food.

Caroverine is used in the treatment of tinnitus (ringing in the ears) and abdominal pain. Caroverine is an oto-neuroprotective (inner ear protective) medication. It works by blocking the action of a chemical messenger in the brain (glutamate) thereby reducing the severity of tinnitus.

At the recent SEC meeting for Neurology and Psychiatry held on 12th and 13th of December 2023, the expert panel reviewed the BE study report of Caroverine Capsules 40mg (additional strength) with a request for CT waiver.

After detailed deliberation, the committee observed that the proposed higher strength is not approved anywhere in the world.

In line with the above, the expert panel opined that the firm is required to submit a therapeutic justification and clinical relevance of higher strength Caroverine Capsules 40mg along with Phase-III clinical trials protocol for further review of the committee.

Also Read: Drug Alert: CDSCO flags 64 drug samples including Aristo's Monocef 500

Caroverinecdscolincolnlincoln pharma
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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