FDA Turns Down a Third Generic Version of Advair

Novartis formulation had been anticipated by mid-year

The FDA has declined to approve Novartis’ generic formulation of fluticasone propionate/salmeterol (Advair, GlaxoSmithKline), according to a report from FiercePharma. Approval of the Novartis’ generic had been anticipated for the first half of 2018.

Novartis said it has received a complete response letter in which the FDA asked for more data on the drug, which aimed to be a substitutable version of the big-selling respiratory drug.  The Swiss drugmaker now says it’s “highly unlikely” the generic will launch this year. Sandoz’ version is the third to be turned away by the FDA.

GlaxoSmithKline investors were cheered by the prospect of at least a partial reprieve from the sales hit the company has said it expects if multiple Advair copies launch midyear, FiercePharma said. It could well face Mylan, however, whose version is set for an FDA action date in June. The company says it could win a nod before then.

Meanwhile, Hikma and Vectura are fighting with the FDA over their own rejections. Vectura has said it’s not sure when the product will launch; it could be as late as 2020.

Sandoz had included the Advair generic in its assumptions for 2018. But apparently, the company wasn’t anticipating a big kick-in from the product this year, perhaps because of that competition. In its statement to FiercePharma, Novartis said its expectations for Sandoz sales growth this year “is unchanged” and “broadly in line with prior year to a slight decline.”

No doubt the company will want to get its application back in as soon as possible. With details scarce on the data the FDA requires, it’s tough to tell when that might be. A launch early next year would be quite different from a launch in late 2019, for Sandoz and for Glaxo, too.

“We will be working with the agency to clarify the points raised in the CRL and will provide further information when available,” said Shawn Silvestri, head of global product development at Novartis’ Sandoz unit, in an emailed statement to FiercePharma. “We are committed to bringing our generic Advair to patients in the U.S. as soon as possible,” he added.

Source: FiercePharma; February 8, 2018.