Hetero Labs Gets CDSCO Panel Nod to Study Tedizolid Phosphate for Acute Bacterial Skin and Skin Structure Infections
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.
