Glenmark Pharmaceuticals has received the final nod from the US health regulator for a generic version of anti-bacterial drug Zyvox (Linezolid tablets, 600 mg). The product is the therapeutic equivalent of Zyvox tablets, 600 mg of Pharmacia and Upjohn Company, a subsidiary of Pfizer. According to IMS Health sales data for the 12 months to October 2015, Zyvox tablets, 600 mg, achieved annual sales of around USD 447.6 million.
Zyvox is an anti-bacterial drug marked for adults and children for treatment of infections such as pneumonia, complicated skin and skin structure infections, including diabetic foot infections.
With this approval, the company’s current portfolio consists of 104 products authorised for distribution in the US marketplace and 62 abbreviated new drug applications (ANDA) pending approval with USFDA.
What is diabetic foot infection?
- Diabetic foot infection, defined as soft tissue or bone infection below the malleoli, is the most common complication of diabetes mellitus.
- Diabetic foot infections are diagnosed clinically based on the presence of at least two classic findings of inflammation or purulence.
- The most common pathogens in diabetic foot infection are aerobic gram-positive cocci, mainly Staphylococcus species.
- Methicillin-resistant Staphylococcus aureus is present in 10% to 32% of diabetic infections and is associated with a higher rate of treatment failure in patients with diabetic foot infection.
