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.
The drug has met all of the Food and Drug Administration's requirements but is facing an automatic stay as the result of litigation with Sanofi, who has claimed patent infringement on it Lantus insulin.
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.
The clarification represents a victory for patients, according to the National Association of Chain Drug Stores, who reached out to the DEA for clarification on the issue in a May letter to the DEA.
With the expansion of availability into Michigan and South Carolina, Rite Aid now offers naloxone dispensing without a prescription in 25 states
In addition to his work pioneering the psychopharmacology field, Dr. Raymond Sackler also was known for his philanthropic efforts.
Gilead’s hepatitis C treatment Vosevi and Puma Biotechnology’s breast cancer drug Nerlynx both earned Food and Drug Administration approval this week.
Diabetes was the seventh leading cause of death in the U.S. in 2015, the CDC reported earlier this week.
The organization has brought onto its board Walgreens VP federal government relations and U.S. public policy Ed Kaleta; Pfizer's regional president North America for rare disease Tolga Tangular; and AstraZeneca’s executive director of access services Blaine Squires.
Perrigo said that it anticipates launching the generic ear drops within 90 days.