Present data on Feropenem Sodium ER tablets: CDSCO to Sun Pharma
New Delhi: In response to the drug-major Sun Pharma's proposal for manufacturing and marketing of Feropenem Sodium Extended Release Tablets, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has opined the firm to present detailed pharmacokinetic data as per regulatory guidelines for review by the Committee.
This came after the firm presented its proposal for manufacturing and marketing of Feropenem Sodium Extended Release Tablets 300mg along with Bioequivalence Study report.
Faropenem is a penem with a tetrahydrofuran substituent at position C2, with broad-spectrum antibacterial activity against many gram-positive and gram-negative aerobes and anaerobes. Compared with imipenem, faropenem has improved chemical stability and reduced central nervous system effects. In addition, faropenem is resistant to hydrolysis by many beta-lactamases.
Faropenem is approved for use in the treatment of upper and lower respiratory tract infections, ear, nose and throat (ENT) infections, genito-urinary infections, skin and skin structure infections, and gynaecological infections.
Feropenem Sodium Extended Release Tablet is also marketed by drug-major Cipla under the brand name FAROBACT 300 ER tablets.
At recent SEC meeting for Antiviral & Antimicrobial dated 21.01.2022, the expert panel thoroughly examined the Sun Pharma's proposal for manufacturing and marketing of Feropenem Sodium Extended Release Tablets 300mg along with Bioequivalence Study report.
After detailed deliberation, the Committee opined that the firm should present detailed pharmacokinetic data as per regulatory guidelines for review by the Committee.
