7/17/2024 Kaleo, Inc. NDA 201739, AUVI-Q (epinephrine injection, USP), for intramuscular or subcutaneous use None None 1/18/2024 Novartis Pharmaceuticals Corporation NDA 209092KISQALI (ribociclib) tablets, for oral use […]

Department of JusticeOffice of Public Affairs FOR IMMEDIATE RELEASEThursday, July 25, 2024 A federal grand jury in Houston returned an indictment today charging an Indian national […]

Department of JusticeU.S. Attorney’s OfficeDistrict of South Carolina FOR IMMEDIATE RELEASEFriday, July 25, 2024 GREENVILLE, S.C. — Richard A. Sheriff, 73, of Easley, has pleaded guilty to […]

Delivery Method: Via Email [email protected] Product: Drugs Recipient: Recipient Name James P. Morrissette Recipient Title CEO Premier Manufacturing Products, LLC 912 46th Lane Unit 204Cape Coral, […]

[embedded content] Español Teething is a normal experience for infants and children, but it can be painful. Many well-meaning parents and caregivers who want to ease […]

What health care providers, compounders and patients should know FDA has received reports of adverse events, some requiring hospitalization, that may be related to overdoses due […]

On This Page Date: October 3, 2024 Time: 8:30 AM – 12:30 PM ET About the Event: The Food and Drug Administration (FDA), in collaboration with […]

On This Page Date: July 25, 2024 Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT (Hosted by CDER SBIA) The FDA collaborated with […]

4/28/2023 NDA-019758 Clozaril (Clozapine) HERITAGE LIFE SCIENCES BARBADOS INC Archive 9/20/2021 NDA-018936 Prozac (Fluoxetine Hydrochloride) ELI LILLY AND COMPANY  Archive 4/11/2019 NDA-022526 Addyi (Flibanserin) SPROUT PHARMACEUTICALS […]