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March 8, 2021

Continuation of a series of letters communicating interim and informal generic drug policy and guidance. Availability of Policy and Procedure Guides, and further operational changes to the generic drug review program

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The FDA published Good Guidance Practices in February 1997. This guidance was developed and issued […]
March 8, 2021

Patient Listening Session Summaries

Previously Conducted Patient Listening Sessions FDA-Requested Patient Listening Session Summaries September 11, 2020 – PML session2: Progressive Multifocal Leukoencephalopathy (PML) August 12, 2020 – SMS: Smith-Magenis […]
March 8, 2021

FDA grants accelerated approval to axicabtagene ciloleucel for relapsed or refractory follicular lymphoma

On March 5, 2021, the Food and Drug Administration granted accelerated approval to axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) for adult patients with relapsed or refractory […]
March 8, 2021

Enzymology Research Center, Inc. – 604613 – 03/01/2021

Product: Drugs Recipient: Recipient Name Troy A. Aupperle Recipient Title Owner Enzymology Research Center, Inc. 332 West Street N.Miltona, MN 56354-8256United States Issuing Office: Office of […]
March 8, 2021

Cipher Pharmaceuticals Inc. C/O Willcox & Savage, P.C. – 08/24/2017

Product: Drugs Recipient: Recipient Name Robert D. Tessarolo Recipient Title President and Chief Executive Officer Cipher Pharmaceuticals Inc. C/O Willcox & Savage, P.C. 440 Monticello AvenueSuite […]
March 5, 2021

Vanda Pharmaceuticals – 576442 – 10/22/2018

TRANSMITTED BY FACSIMILE OCT 22, 2018 Mihael H. Polymeropoulos, M.D.President and Chief Executive OfficerVanda Pharmaceuticals Inc.2200 Pennsylvania Ave NW, Suite 300EWashington, DC 20037 RE: NDA 022192 FANAPT® […]
March 5, 2021

MannKind Corporation – 578282 – 10/05/2018

Delivery Method: Electronic Mail and Facsimile Product: Drugs Recipient: Recipient Name Michael Castagna, PharmD, MBA Recipient Title Chief Executive Officer MannKind Corporation One Casper StreetDanbury, CT […]
March 5, 2021

Vanda Pharmaceuticals – 576442 – 11/21/2018

Product: Drugs Recipient: Recipient Name Mihael H. Polymeropoulos, M.D. Recipient Title President and Chief Executive Officer Vanda Pharmaceuticals 2200 Pennsylvania Ave NW, Suite 300EWashington, DC 20037United […]
March 5, 2021

Metuchen Pharmaceuticals, LLC. – 590713 – 08/16/2019

Product: Drugs Recipient: Recipient Name Greg Ford Recipient Title President and Chief Executive Officer Metuchen Pharmaceuticals, LLC. 4400 Route 9 South, Suite 1000Freehold, NJ 07728United States […]
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