10/06/2017

Nexagen, LLC

Atlanta District Office

CGMP/Dietary Supplement/Adulterated

Not Issued *

10/16/2017

Kim Chemicals Private Ltd.

Center for Drug Evaluation and Research

CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug

Not Issued *

10/17/2017

Town and Country Compounding and Consultation Services, LLC

New Jersey District Office

Compounding Pharmacy/Adulterated Drug Products

Not Issued *

10/18/2017

Accelerated Analytical Laboratories Inc.

Detroit District Office

CGMP/Finished Pharmaceuticals/Adulterated

Not Issued *

10/20/2017

Aztex Enterprises Ltd.

Center for Drug Evaluation and Research

CGMP/Finished Pharmaceuticals/Adulterated

Not Issued *

10/23/2017

Panther Sports Nutrition

New Jersey District Office

Unapproved New Drugs/Misbranded

Not Issued *

10/23/2017

Ironmag Labs

Los Angeles District Office

Unapproved New Drugs/Misbranded

Not Issued *

10/23/2017

Infantry Labs LLC

Detroit District Office

Unapproved New Drugs/Misbranded

Do Biosimilars Require Clinical Trials?

Applied Clinical Trials Online (press release) (blog)-Oct 30, 2017

FDA has mapped out a development pathway for biosimilars that relies primarily on structural analysis and preclinical and clinical pharmacology studies to ...

Drugmaker set to profit from an opioid it said was unsafe

WGNO-Oct 30, 2017

Endo contended that the new Opana ER and its hard coating deterred abuse, but this summer, the FDA disagreed. In June, the regulatory agency concluded that ...

Endo to receive royalties from generic opioid it once called 'unsafe ...
Becker's Hospital Review-21 hours ago

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