October 27, 2023

• FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection

This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.

"Amazon Pharmacy is focused on making it faster and more convenient for patients to get prescription medications. The company's moves come as brick-and-mortar drugstores are limiting pharmacy hours and even closing locations." - Heather Landi

 

Hospital 340B drug pricing program policy reversal a 'gut punch'

The federal government reversed a policy designed to streamline 340B certifications during the COVID-19 pandemic.

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10/10/2023

08/28/2023

MKK Imports

Division of West Coast Imports

Foreign Supplier Verification Program (FSVP)

 

10/17/2023

09/19/2023

Hygienic Labs, LLC

Center for Drug Evaluation and Research | CDER

Refusal to Provide Access to and Copying of Records

 

10/25/2023	10/24/2023	Abbott Laboratories	Center for Biologics Evaluation and Research (CBER)	Dietary Supplement/Adulterated
10/24/2023	10/05/2023	Golden Natural Products	Division of Northeast Imports	Foreign Supplier Verification Program (FSVP)
10/24/2023	10/04/2023	Embryll Life Sciences, Inc.	Center for Veterinary Medicine	Unapproved New Animal Drug/Adulterated
10/24/2023	08/21/2023	Suther Feeds, Inc.	Division of Human and Animal Food Operations West II	CGMP/Medicated Feeds/Adulterated

 Agency Information Collection Activities; Proposed Collection; Comment Request; Cattle Materials Prohibited From Use in Animal Food or Feed

October 12, 2023; 88 FR 70676

 

Congress eyes endgame for PBM legislation

Pharmacy benefit managers such as CVS Caremark, Express Scripts and Optum Rx face new transparency rules and restrictions on how they make money under a legislative package coalescing on Capitol Hill.

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10/10/2023

09/08/2023

Shantaba LLC

Division of Southwest Imports

Foreign Supplier Verification Program (FSVP)

 

10/10/2023	09/19/2023	Abiomed Inc.	Division of Medical Device and Radiological Health Operations East	CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded
10/10/2023	10/02/2023	www.gorillahealing.com	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded
10/10/2023	09/26/2023	Antonio E. Blanco, M.D./Vista Health Research, LLC	Center for Drug Evaluation and Research | CDER	Clinical Investigator
10/10/2023	10/02/2023	www.semaspace.com	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded
10/10/2023	09/29/2023	www.alphamedstore.com	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded
10/10/2023	08/28/2023	MKK Imports	Division of West Coast Imports	Foreign Supplier Verification Program (FSVP)
10/10/2023	10/02/2023	Seoul Cosmetics Co., Ltd.	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
10/10/2023	08/24/2023	Tijuana’s Produce Inc.	Division of West Coast Imports	Foreign Supplier Verification Program (FSVP)
10/10/2023	08/07/2023	Ikal LLC	Division of Southwest Imports	Foreign Supplier Verification Program (FSVP)
10/10/2023	09/29/2023	Kari-Fresh LLC	Division of Southwest Imports	Foreign Supplier Verification Program (FSVP)