11/21/2023	11/08/2023	www.directpharmashop.net	Center for Drug Evaluation and Research | CDER	Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
11/21/2023	10/20/2023	Elemental Herbs Inc. d/b/a ALL good	Division of Pharmaceutical Quality Operations IV	CGMP/Finished Pharmaceuticals/Adulterated

 

11/21/2023	11/16/2023	Discover Health, LLC d/b/a Discover CBD and Strain Snobs	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drugs/Animal Drugs/Human Foods/Animal Foods/Adulterated/Misbranded
11/21/2023	11/17/2023	Cipla Limited	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Adulterated
11/21/2023	11/08/2023	National Chemical Laboratories	Office of Pharmaceutical Quality Operations	CGMP/Finished Pharmaceuticals/Adulterated
11/21/2023	09/20/2023	Raven Route	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
11/21/2023	10/20/2023	Elemental Herbs Inc. d/b/a ALL good	Division of Pharmaceutical Quality Operations IV	CGMP/Finished Pharmaceuticals/Adulterated
11/21/2023	11/09/2023	Wan-Gee Foods, Inc.	Division of Human and Animal Food Operations West II	CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
11/21/2023	11/17/2023	AmLion Toothpaste Mfg. Sdn. Bhd.	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Adulterated
11/21/2023	11/15/2023	Xiamen Wally Bath Manufacture Co., Ltd.	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Adulterated
11/21/2023	10/26/2023	Brenntag Great Lakes, LLC	Division of Pharmaceutical Quality Operations III	CGMP/Finished Pharmaceuticals/Adulterated
11/21/2023	11/16/2023	Cerci Kozmetik Ve Otel Ekipmanlari Pazarlama Ic Ve Dis Ticaret Limited Sirketi	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Adulterated

 "On Tuesday, November 7, the FDA issued a warning letter to Nic Nac Naturals, LLC for the marketing of their unauthorized dissolvable nicotine products, which the company describes as “nicotine mints” and resemble a pack of mints. The manufacturer markets these tobacco products in a variety of mint and fruit flavors, all of which come in two nicotine strengths (3 milligrams or 6 milligrams). These products are of particular concern because of their resemblance to popular candies and the potential to cause severe nicotine toxicity or even death if accidentally ingested by young children."  From FDA Roundup

" On Monday, the FDA issued a warning letter to Amazon.com, Inc. for the firm’s distribution of “Similasan Pink Eye Relief,” “The Goodbye Company Pink Eye,” “Can-C Eye Drops,” “Optique 1 Eye Drops,” “OcluMed Eye Drops,” “TRP Natural Eyes Floaters Relief” and “Manzanilla Sophia Chamomile Herbal Eye Drops” products. These products are not generally recognized as safe and effective for their claimed uses, including temporary relief of minor eye symptoms such as excessive watery (clear) discharge, sensation of grittiness, redness and burning, or pink eye. Therefore, these products are categorized as “new drugs” under the Federal Food, Drug & Cosmetic Act. Ophthalmic drug products are especially concerning from a public health perspective. Products intended for use in the eyes generally pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses."  From FDA Roundup

 

• Identification of Medicinal Products (IDMP) is a set of five standards developed by the International Organization for Standardization (ISO). Together, these five standards, along with their respective technical specifications, will make it possible to uniquely identify medicinal products globally and to standardize the electronic exchange of medicinal product data.
• FDA’s recent guidance on IDMP explains FDA’s position and progress on aligning the Agency’s standards to IDMP standards to identify and describe marketed medicinal products with the goal of harmonizing the standards for the international exchange of medicinal product data. More...

 

 TOPICS COVERED

• Overview of the FDA Guidance on IDMP – Implementation and Use
• Status of the international projects focused on global implementation
• FDA will discuss specific pharmacovigilance and drug shortage use cases demonstrating the value-added impact that IDMP will deliver

 

Upstart PBMs aim to shake up the market

A cadre of small pharmacy benefit managers seeking to snatch market share from CVS Caremark, OptumRx and Express Scripts is pinning its hopes on a new business model and new federal policy.

READ MORE >

 

Date	Application Number	Sponsor	Product Name	Species	Indications for Use/Effect of the Supplement	Public Documents
October 20, 2023	NADA 141-564	Pharmgate Inc.	Pennchlor and Rumensin (chlortetracyclinel and monensin)	Replacement beef and dairy heifers	This supplement provides for the addition of replacement beef and dairy heifers with the following indications: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline and for the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii in replacement beef and dairy heifers; and For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline and for increased rate of weight gain in replacement beef and dairy heifers.	FOI Summary
October 13, 2023	NADA 141-336	ECO LLC	AIVLOSIN (62.5% w/w tylvalosin as tylvalosin tartrate)	Female swine intended for breeding (replacement gilts, gestating replacement gilts, gestating sows, lactating sows, and weaned sows)	This supplement provides for the addition of female swine intended for breeding (replacement gilts, gestating replacement gilts, gestating sows, lactating sows, and weaned sows) to the classes approved for the control of porcine proliferative enteropathy and control of swine respiratory disease indications, and provides for removal of the precaution “Not for use in lactating or pregnant females or females intended for breeding” from the labeling.	FOI Summary
October 11, 2023	NADA 141-572	Virbac AH, Inc.	AYRADIA (metronidazole)	Dogs	For the treatment of Giardia duodenalis infection in dogs.	FOI Summary

 

10/24/2023

10/05/2023

Golden Natural Products

Division of Northeast Imports

Foreign Supplier Verification Program (FSVP)

 

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

 

10/31/2023	03/30/2023	ALI Pharmaceutical Manufacturing, LLC	Division of Pharmaceutical Quality Operations III	CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
10/31/2023	10/20/2023	Samm Solutions, Inc., d.b.a. BTS Research	Center for Drug Evaluation and Research | CDER	Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
10/31/2023	10/20/2023	WAVi Co.	Division of Medical Device and Radiological Health Operations West	Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
10/31/2023	10/20/2023	Maria W. Greenwald, M.D.	Center for Drug Evaluation and Research | CDER	Clinical Investigator