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October 5, 2020

CDER proposes withdrawal of approval for Makena

[10/5/2020] Today, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) proposed that Makena (hydroxyprogesterone caproate injection) be withdrawn from the market […]
October 5, 2020

Makena (hydroxyprogesterone caproate injection) Information

CDER Statement 10/5/2020 – CDER proposes withdrawal of approval for Makena The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) proposed that […]
October 5, 2020

Clinical Outcome Assessments (COA) Qualification Program Submissions

The tables below list information about submissions to the FDA Clinical Outcome Assessments (COA) Qualification Program for which final COA qualification determinations have not yet been […]
October 5, 2020

Rare Diseases at FDA

Over 7,000 rare diseases affect more than 30 million people in the United States. Many rare conditions are life-threatening and most do not have treatments. Drug, […]
October 5, 2020

Substance Use Tied to Increased COVID-19 Risk Substance Use Tied to Increased COVID-19 Risk

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Substance use disorders (SUD), particularly opioid addiction and smoking, are tied to […]
October 5, 2020

CTX Lifesciences Private Ltd. – 577416 – 07/12/2019

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Kanak Jariwala Recipient Title Director CTX Lifesciences Private Ltd. Block No. 251-252, Sachin-Magdalla RoadGIDC, Sachin, Surat […]
October 5, 2020

Ningbo Pulisi Daily Chemical Products Co., Ltd – 577795 – 08/13/2019

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Wenjun Qian Recipient Title President and General Manager Ningbo Pulisi Daily Chemical Products Co., Ltd Fangjia […]
October 5, 2020

Promise Pharmacy, LLC – 587148 – 07/29/2019

Delivery Method: UPS Product: Drugs Recipient: Recipient Name Dipti V. Patel Recipient Title Owner Promise Pharmacy, LLC 31818 US Highway 19 NPalm Harbor, FL 34684-3713United States […]
October 5, 2020

NingBo Huize Commodity Co., Ltd. – 581345 – 08/02/2019

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Wenxuan Han Recipient Title General Manager/Owner NingBo Huize Commodity Co., Ltd. 14 Lizhou Road Yuyao, ZhejiangZhejiang […]
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