Zydus Cadila scores twin FDA approvals
Indian pharmaceutical firm Zydus Cadila has announced that the US Food and Drug Administration (FDA) has given the go-ahead for the marketing and sale of two of its products in the US, bringing the firm’s total drug approvals to more than 100 since 2004.
"Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market fluconazole tablets in strengths of 50 mg, 100 mg, 150 mg and 200 mg and Clobetasol Propionate spray, 0.05%," the company revealed in a BSE filing.
Fluconazole is an antifungal medication, a generic version of Bayer’s Canesten. It is used to treat a range of fungal infections by inhibiting the fungal cytochrome P450 enzyme 14α-demethylase. Clobetasol Propionate is used as a treatment for various skin disorders.
Zydus made news in September last year when it was swept up in a lawsuit from Pfizer, alongside a number of Indian drug companies including Sun Pharma, for allegedly attempting to copy its rheumatoid arthritis treatment Xeljanz.
- AbbVie’s Humira meets endpoint in eye disease study
- The March 2017 issue of Pharmafocus is now live!
- FDA Priority Review for Pfizer investigational leukaemia drug
- FDA rejects Amphastar’s application for NDA for intranasal overdose treatment
- FDA approves Valeant plaque psoriasis drug despite suicide concerns