Daiichi Sankyo-controlled Indian drug major Ranbaxy Laboratories Ltd has received first-to-file US Food and Drug Administration (FDA) approval, with 180-day marketing exclusivity to sell a generic version of a hypertension and heart failure drug in the world’s largest drug market, it said on Friday.
The approval has been issued to OHM Laboratories Inc, a wholly owned subsidiary of Ranbaxy.
It has received approval from the US drug regulator to manufacture and market Valsartan 40 mg, 80 mg, 160 mg and 320 mg tablets on an exclusive basis.
Valsartan is indicated for the treatment of high blood pressure and heart failure. It is a generic version of Novartis’ innovator branded drug Diovan. The total annual market sale of Diovan is pegged at $2.19 billion.
Valsartan will be manufactured at OHM facilities located in New Brunswick, New Jersey.
Bill Winter, vice president, sales and distribution, Ranbaxy North America, said, “We have been anticipating marketing approval of Valsartan for some time now and we are very pleased that this has finally come to fruition. For the US healthcare system, Valsartan adds to the growing portfolio of generic medications which have played such an integral role in helping alleviate the burden of rising costs of treatment.”
Ranbaxy has been under the scanner of US FDA over various issues which had led the US drug regulator to ban import of products made at all its Indian plants.
Earlier this year US FDA had prohibited Ranbaxy from producing and selling active pharmaceutical ingredients for American markets from its Toansa facility in Punjab, citing manufacturing violations. With this, all Indian plants of the company had been banned from shipping products for sale in the US.
Previously, US FDA had banned Ranbaxy from selling products made at its factories in Paonta Sahib, (Himachal Pradesh), Dewas (Madhya Pradesh) and Mohali (Punjab) over irregularities.
The latest FDA approval for its heart drug also comes as a bonus for Sun Pharmaceuticals which is acquiring Ranbaxy to merge it with itself in a $4 billion deal, including debt.
Ranbaxy scrip shot up over 8 per cent in intra-day trades and was quoting at Rs 498.1 a share, up 5.59 per cent in mid-day trades in a strong Mumbai market on Friday. Sun Pharma scrip was also up over 4 per cent in mid-day trades.
(Edited by Joby Puthuparampil Johnson)