FDA nod for DRLs anti-depressant

Hyderabad, Oct 29 | Updated: Oct 30 2004, 06:10am hrs
Dr Reddys Laboratories has received the final US Food and Drug Administration (US FDA) approval for citalopram hydrobromide tablets of 10mg, 20mg and 40mg.

The drug is the generic equivalent of Forest Laboratories Celexa and is indicated for the treatment of depression.

According to pharma industry journals, the product has an annual US brand sales of about $1.4 billion. Citalopram hydrobromide is considered to be a blockbuster among the available class of drugs for treatment of depression.

The good news for Dr Reddys comes amid Novo Nordisk deciding to terminate clinical development of its partial PPAR (peroxisome proliferator activated receptor) gamma against Balaglitazone (DRF 2593), oral treatment for patients with Type 2 diabetes and a fall in its net profit for the second quarter.

With the approval, Dr Reddys will commence commercial marketing of this product immediately. Recently, the company had also received a tentative approval from US FDA for the generic product, Finasteride.