Zydus Lifesciences Gets US FDA Approval To Manufacture Fludrocortisone Acetate Tablets

Zydus Lifesciences Ltd. announced on Thursday that the company has received final nod from the United States Food and Drug Administration to manufacture Fludrocortisone Acetate tablets USP, 0.1 mg.

Fludrocortisone acetate tablets are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome.

The drug will be produced at the company’s manufacturing site at Moraiya, Ahmedabad.

Fludrocortisone acetate tablets had annual sales of $19.9 million in the United States. The group now has 400 approvals and has so far filed over 465 Abbreviated New Drug Application, or ANDA since the commencement of the filing process in fiscal 2004.

Earlier on Sept. 27, the company partnered with Lucknow-based CSIR-Central Drug Research Institute to develop a new treatment for osteoporosis induced by chronic kidney disease. The collaborative research agreement was inked between the parties to develop oral medication through the discovery of small molecule inhibitors of Sclerostin.

On Sept. 13, Zydus Lifesciences signed a pact with US-based Viwit Pharmaceuticals for two MRI injectables and contrast agents. The pact has been inked for gadobutrol injection, a generic version of Gadavist; and gadoterate meglumine injection, which will be the generic substitute for Dotarem. They will be sold exclusively in the US market.

Shares of Zydus Lifesciences closed 0.14% higher at Rs 1,021.50 apiece on the NSE, compared to a 0.89% decline in the benchmark Nifty 50.

The stock has risen 72.94% in the last 12 months and 42.12% on a year-to-date basis.

Twelve out of the 32 analysts tracking the company have a 'buy' rating on the stock, 10 recommend a 'hold' and 10 suggest a 'sell', according to Bloomberg data. The average of 12-month analyst price targets implies a potential upside of 17.2%.