FDA approves Apotex’s generic budesonide nasal spray

Apotex says that it launched a generic budesonide nasal spray in the US on May 13, 2014 following the previous day’s approval of the product by the FDA. The new product, with a strength of 32 mcg/spray, is a generic equivalent for AstraZeneca’s Rhinocort Aqua.

Apotex’s suggested average wholesale price is $160.53, which appears to be similar to the retail price of Rhinocort Aqua in the US with a coupon. At least one pharmacy benefit manager in the US has excluded Rhinocort Aqua from its preferred drug list.

Apotex submitted an ANDA for the generic budesonide nasal spray in 2007, after which AstraZeneca announced that it would not enforce patents related to Rhinocort Aqua.

In a recent talk, Bing Li of the FDA discussed the agency’s backlog of generic nasal spray ANDAs and advice for speeding approval.