Glenmark gets CDSCO panel conditional nod to Minocycline Hydrochloride Topical Gel

Published On 2021-01-26 05:30 GMT | Update On 2021-01-26 05:31 GMT

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has opined for the grant of permission to Glenmark Pharma for Minocycline Hydrochloride Topical Gel 4% for Topical use. However, the permission comes with a couple of conditions, including, presentation of Phase IV CT protocol before the committee for further consideration.

This came after the drugmaker, Glenmark Pharma presented their proposal along with the In Vitro Permeation Test (IVPT) report and also submitted their justification for the waiver of Bioequivalence (BE) and Clinical Trial (CT) Study to the Subject Expert Committee (SEC) of CDSCO.

Also Read: Glenmark secures USFDA nod for Tadalafil, Gabapentin Enacarbil, Apremilast Tablets

Minocycline, a tetracycline antibiotic is known for its usages in the treatment of a number of bacterial infections such as pneumonia. The drug is also used to treat acne vulgaris, other skin infections such as methicillin-resistant Staphylococcus aureus, Lyme disease, etc.

Glenmark Pharma presented the proposal along with the report of IVPT, a justification for BE, and CT study waiver.

Minocycline Hydrochloride Topical Foam 4% is already approved in the USA.

The SEC committee, in its 54th meeting held on 12.01.2021 at CDSCO HQ New Delhi reviewed all the proposals related to Dermatology and Allergy and made some recommendations regarding the same. Among these, Glenmark's proposal was examined as well.

After detailed deliberation of the proposal of Glenmark Pharma, the committee opined that grant of permission for Minocycline Hydrochloride Topical Gel 4% may be considered subject to the condition that the firm should submit the following:

1. Propionibacterium acnes sensitivity to minocycline and incidence of Hyperpigmentation in the Indian population.

2. The firm should present Phase IV CT protocol before the committee for further consideration.

A global research-led pharmaceutical company, Glenmark's key therapy focus areas globally are respiratory, dermatology, and oncology.

Also Read:FIRST: Glenmark launches Remogliflozin, Vildagliptin FDC drug priced at Rs 14 per tablet to treat diabetes in India

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

MD Bureau

Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers. Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in.

Comments Policy

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Glenmark gets CDSCO panel conditional nod to Minocycline Hydrochloride Topical Gel

Similar News

NPPA Caps Prices of Ipratropium, Sodium Nitroprusside, Two Other Essential Drugs

Akum Pharma Asked to Submit Safety Data for Alzheimer's Drug Combo In Elderly Indian Patients

Aurobindo Pharma net profit drops 10 percent to Rs 824 crore in Q1

MSN Labs Gets CDSCO Panel Nod to Begin Phase III Trial of Cenobamate Tablets, With Safety Caveat

USFDA appoints Sean Keveney as Chief Counsel

Bristol Myers Squibb Breyanzi application accepted for priority review by USFDA for Marginal Zone Lymphoma

Cipla Bommasandra facility gets VAI classification from USFDA

Eli Lilly expands India presence with inauguration of Hyderabad site