Aurobindo Pharma has secured FDA approval for its cephalexin tablets, available in 250 mg and 500 mg dosages. This approval marks a significant step in providing a generic alternative to Eli Lilly’s Keflet, a widely used antibiotic. The availability of a generic option is expected to enhance patient access and potentially lower healthcare costs.
The approved cephalexin tablets are indicated for the treatment of infections caused by susceptible strains of designated microorganisms. Cephalexin is a first-generation cephalosporin antibiotic commonly prescribed for various bacterial infections, including respiratory tract infections, skin and soft tissue infections, and urinary tract infections. Its mechanism of action involves inhibiting bacterial cell wall synthesis, leading to bacterial cell death.
Aurobindo was granted Competitive Generic Therapy (CGT) designation for its cephalexin tablets, 250 mg and 500 mg. This designation makes Aurobindo eligible for 180 days of shared generic drug exclusivity, incentivizing the company to bring this important medication to market. The CGT pathway is designed to expedite the approval of generic drugs for which there is limited competition, ultimately benefiting patients.
The product is expected to be launched in the third quarter of 2025. This launch will provide healthcare providers and patients with a cost-effective alternative to the brand-name drug, Keflet. The introduction of generic cephalexin tablets is anticipated to increase market competition and potentially drive down prices, making the medication more accessible to a broader patient population.
