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January 29, 2021

Weight Loss, Male Enhancement and Other Products Sold Online or in Stores May Be Dangerous

Image Español Whether you’re looking to buy weight loss, male enhancement, or certain other products, these days you’re apt to look for them online, rather than […]
January 28, 2021

2018 First Generic Drug Approvals

  ANDA Number Generic Name ANDA Applicant Brand Name ANDA Approval Date ANDA Indication+ 99 210618 Hydroxyprogesterone Caproate Injection USP, 1250 mg/5 mL (250 mg/mL) Multi-dose […]
January 28, 2021

Small Business Assistance

The Food and Drug Administration (FDA) recognizes that dealing with a large organization can frequently be a time consuming, frustrating experience. Although there is no acceptable […]
January 28, 2021

Allimax Us – 609328 – 01/12/2021

Product: DrugsFood & Beverages Recipient: Recipient Name Bobbi Walton Allimax Us 500 W Superior StUnit 2205/#2205Chicago, IL 60654-8150United States [email protected] WARNING LETTER Date:      January 12, […]
January 28, 2021

AusarHerbs – 610976 – 01/12/2021

Product: DrugsFood & Beverages Date:   January 12, 2021 RE: Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that […]
January 28, 2021

Information about Nitrosamine Impurities in Medications

A. FDA has ongoing assessment, surveillance, compliance and pharmaceutical quality efforts across every product area, and we will continue to work with drug manufacturers to ensure […]
January 28, 2021

Division of Oncology 2 (DO2)

The Division of Oncology 2 (DO2) regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs) and Biologic Licensing Applications (BLAs) for the following therapeutic areas: […]
January 28, 2021

Meitheal Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Cisatracurium Besylate Injection, USP 10mg per 5mL Due to Mislabeling

Summary Company Announcement Date: January 27, 2021 FDA Publish Date: January 27, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Mislabeling Company Name: Meitheal […]
January 27, 2021

Office of Prescription Drug Promotion (OPDP) Metrics

Number of core initial promotional campaign material reviews completed in the month Dictionary: “Launch” materials are the initial promotional materials that companies disseminate to healthcare professionals […]
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