Pharmacy News

Image description

FDA chief promises ANDA submission guidance by year’s end

At a public meeting on July 18, Food and Drug Administration commissioner Scott Gottlieb said that by the end of the year, the agency would develop an internal strategy for dealing with abbreviated new drug applications, as well as a guidance on the best submission practices.

Image description

Teligent gets FDA nod for generic Erygel

SILVER SPRING, Md. — The Food and Drug Administration has given Teligent approval for its third approval this year. The company announced the approval of its generic of Erygel (Erythromycin Topical Gel, 2%) on Friday.

“Teligent now has 19 topical generic pharmaceutical products in the US portfolio, in addition to our four U.S. injectable products,” Teligent president and CEO Jason Grenfell-Gardner said.