Ranbaxy, Cadila gets USFDA nod for Carvedilol

MUMBAI: Ranbaxy Laboratories and Cadila Healthcare have received approval from the USFDA for Carvedilol tablets in the strengths - 3.125 mg, 6.25 mg, 12.5, and 25 mg. The US FDA has determined Ranbaxy formulations to be bio-equivalent of GlaxoSmithKline’s drug Coreg.

Ranbaxy’s total annual market sales for Carvedilol tablets stood at $1.6 billion, while that of Cadila was at $1.24 billion in the US market.

Carvedilol is used for the treatment of mild-to-severe heart failure. Carvedilol also reduces cardiovascular mortality. The tablets will be manufactured at Ohm Laboratories facility in New Jersey, Ranbaxy said in a notice to BSE.

While Ranbaxy has got the nod for manufacture and marketing of the drug, Cadila has received approval only for marketing.

Ranbaxy Laboratories shares closed up 3.53 per cent at Rs 414.05 on BSE with volume traded at 5,40,212 against two-week average of 3,65,122 shares.

Cadila Healthcare shares closed up 0.25 per cent at Rs 325.00 on BSE with volume traded at 14,196 against two-week average of 12,043 shares.