Camargo

NOVEMBER 11, 2020

In October, Antares Pharma licensed Ferring Pharmaceuticals’ Nocdurna® (desmopressin acetate) sublingual tablet , which was approved in 2018 for the same indication as Noctiva and has a boxed warning highlighting the same risks. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.

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Camargo

DECEMBER 9, 2020

If you are facing an FDA remote review, Camargo can help design a comprehensive approach in order to avoid such pitfalls. Approval of the Month: Alnylam to Use Value-Based Agreements for Ultra-rare Disease Treatment. Unapproved Drug Initiative Ends. In November, the FDA ended its Unapproved Drug Initiative.

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The Pharma Data

DECEMBER 28, 2020

Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. However, not all forward-looking statements contain these words.

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The Pharma Data

DECEMBER 4, 2021

“The launch of our first-to-market authorized generic version of Epiduo® Forte Gel in the U.S. provides patients with another important treatment option,” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA. Currently, 1 in 11 generic prescriptions dispensed in the U.S. IMPORTANT SAFETY INFORMATION.

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Doctors Doctor Medicine Production 52

FDA Law Blog

JANUARY 11, 2022

Teva , the generic industry has been waiting with bated breath to see whether the section viii carve-out (and thus skinny-labeled generic drugs) will survive. Hikma , the generic industry can have some hope. Koblitz — Since the August 2021 decision in GSK v. The procedural background of Amarin v.

FDA Approval 52

FDA Approval Production Branding Drugs 52

FDA Law Blog

JANUARY 11, 2022

Teva , the generic industry has been waiting with bated breath to see whether the section viii carve-out (and thus skinny-labeled generic drugs) will survive. Hikma , the generic industry can have some hope. Koblitz — Since the August 2021 decision in GSK v. The procedural background of Amarin v.

FDA Approval 52

FDA Approval Production Branding Drugs 52

XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir. billion in 2022, a 23.43

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