US regulator rescinds approval to generics Valcyte & Nexium
In the latest standoff between an Indian pharmaceutical company and the US regulator, Ranbaxy Laboratories is suing the US Food and Drug Administration (USFDA), challenging the latter’s decision to rescind the tentative approval granted to two generic drugs manufactured by the company.
Ranbaxy has said that the US regulator issued the order without allowing the company a chance to respond in the matter.
“The agency issued its decision with no prior notice to Ranbaxy. It gave Ranbaxy no opportunity to comment on the issues raised in that decision,” the Gurgaon-based company said in a court filing in connection with the lawsuit it has filed in the US District Court of Columbia on November 14. “And the agency had no power to issue its decision.”
The lawsuit refers to approvals granted to two drugs — antiviral Valcyte and acid-reflux therapy Nexium. Both drugs, between them, earned their innovator a revenue of nearly $8.5 billion in calendar year 2013, according to Bloomberg Intelligence.
On November 6, the USFDA issued its final decision, stating that it is rescinding the tentative approval granted to Ranbaxy to manufacture generic versions of these drugs, citing quality-related issues identified at the company’s manufacturing plants. The agency also expressly stated that the company lost its 180-day marketing exclusivity granted for generic Valcyte. The next day, on November 7, USFDA granted approval to Dr Reddy’s Laboratories and Endo Pharmaceuticals for generic Valcyte.
Ranbaxy said that the USFDA had witheld its decision to grant marketing exclusivity to the company on the sale of the other drug, generic Nexium, till another potential applicant was ready with its version of the drug.
“Even so, there is no doubt regarding the impact of FDA’s decision: Agencies must treat like cases alike,” Ranbaxy said in its lawsuit. Ranbaxy argued that the USFDA knew on the date of granting tentative approval that there were issues with the facilities and that a subsequent manufacturing audit report showed that they were ironed out.
Ranbaxy, bought over by Sun Pharmaceuticals from Daiichi Sankyo in April, wants the court to direct the USFDA not to approve or allow any generic version of both the drugs to be sold in the US, until the conclusion of Ranbaxy’s 180-day exclusivity period.
Ranbaxy’s manufacturing facilities in India that were to be engaged in production of generic Valcyte and Nexium were its Paonta Sahib and Dewas plants in Punjab.
In 2006 and 2008, the USFDA identified shortcomings in the manufacturing practices at several of Ranbaxy’s plants, including Dewas and Paonta Sahib. This was after it had granted tentative approvals to the company to produce the two generic drugs.