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Hetero Labs Gets CDSCO Panel Nod to Study Tedizolid Phosphate for Acute Bacterial Skin and Skin Structure Infections
![Hetero Labs Gets CDSCO Panel Nod to Study Tedizolid Phosphate for Acute Bacterial Skin and Skin Structure Infections Hetero Labs Gets CDSCO Panel Nod to Study Tedizolid Phosphate for Acute Bacterial Skin and Skin Structure Infections](https://medicaldialogues.in/h-upload/2024/08/16/750x450_248190-hetero-lab-new-50.webp)
New Delhi: Hetero Labs has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct a phase III clinical trial study for the new drug Tedizolid Phosphate 200mg tablet and Tedizolid Phosphate for injection 200mg/vial for treatment of adult patients with acute bacterial skin and skin structure infections.
This came after the firm presented the proposal for a grant of permission to conduct the Phase III clinical trial study for the new drug Tedizolid Phosphate 200mg tablet and Tedizolid Phosphate for injection 200mg/vial for treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) via Protocol No. HCR/III/TEDABS/03/2024, dated 26.03. 2024 before the committee.
Tedizolid phosphate is an oxazolidinone class antibiotic that inhibits bacterial protein synthesis and is proven to be effective in the treatment of certain Gram-positive bacterial infections.
Tedizolid is a member of the oxazolidinone class of antibiotics, which includes the previously approved linezolid, and is generally effective against multidrug-resistant Gram-positive bacteria. Tedizolid is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and is generally more effective and more tolerable than linezolid
At the recent SEC meeting for antimicrobials and antivirals held on July 25, 2024, the expert panel reviewed the proposal for the grant of permission to conduct the Phase III clinical trial study for the new drug Tedizolid Phosphate 200 mg tablet and Tedizolid Phosphate for injection 200 mg/vial for treatment of adult patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI).
After detailed deliberation, the committee recommended the grant of permission to conduct a phase III clinical study as per protocol presented by the firm.
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-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: editorial@medicaldialogues.in. Contact no. 011-43720751