J B Chemicals & Pharmaceuticals today said it has received US health regulator's nod to market a generic version of diclofenac sodium tablets, an anti-inflammatory drug, in the American market.
The company has received approval from US Food and Drug Administration (USFDA) for its abbreviated new drug application for diclofenac sodium tablets in strengths of 25 mg and 50 mg, J B Chemicals said in a filing to the National Stock Exchange (NSE).
The company already markets 75 mg tablets of diclofenac sodium tablets in the US market. With this new approval, the company has now full range of the drug to offer in the US market, it said.
As the firm has established partners in the US, it expects to commercialise this approval in fourth quarter of this year, it added.
The estimated market in the US for diclofenac sodium formulations per annum is nearly $400 million, it said.
Shares of J B Chemicals & Pharmaceuticals today closed at Rs 135.70 on the NSE, up 8.96 per cent from its previous close.
