After many regulatory bans Ranbaxy gets FDA approval for producing Generic Diovan

Indian drug manufacturer, Ranbaxy Laboratorieshas received approval from the U.S. Food and Drug Administration (FDA) to produce generic version of Novartis' blockbuster blood pressure drug Diovan in the US. The company was to begin Diovan production in late 2012, but the formulation plant in India that Ranbaxy Laboratories planned to use to produce the generic was under FDA import alerts. The finished dose of the drug will now be made at the Ranbaxy’s New Jersey-based Ohm Labs unit, which is the only FDA-approved Ranbaxy plant allowed to make drugs for the United States. FDA spokesman Christopher Kelly said that the agency approved the Ohm Laboratories plant to make valsartan, the generic of Diovan, in 40 mg, 80 mg, 160 mg and 320 mg doses.

It is still unclear whether Ranbaxy will go in for a third-party manufacturing for the drug, and from which company it will obtain the API. Ranbaxy's sales head said that the production of the drug will begin as soon as sufficient supplies are manufactured to meet the needs of the market. Novartis’s best-selling drug Diovan went off patent in September 2012. The first company to successfully challenge a drug's patent gets the exclusive right to produce it for six months. But Ranbaxy's poor production quality at its Indian facilities delayed the launch of generic Diovan by almost two years. Ranbaxy’s domestic plants at Poanta Sahib (Himachal Pradesh), Dewas (Madhya Pradesh) and Mohali (Punjab) have been barred from supplying drugs to the US. Despite the delay in approval, Ranbaxy will be the first drug maker to launch generic of Diovan in the United States, and will be entitled to six months of exclusive marketing rights.

Ranbaxy's launch of Diovan is also good news for the 17 other drug manufacturers who can produce generic copies of the drug once Ranbaxy's exclusivity period expires.Novartis will continue to market both its branded and generic versions of Diovan. Ranbaxy also has exclusive rights to make generic versions of acid-reflux drug Nexium and Valcyte, intended to fight infections in AIDS patients. Generic versions of these drugs are still delayed because of Ranbaxy's quality issues.