Azurity Pharmaceuticals, Inc. — a pioneer drug company that markets its FDA-approved oral vancomycin hydrochloride solution, FIRVANQ® — has sued Edge Pharma, LLC, an outsourcing facility operating pursuant to section 503B of...more
2/26/2020
/ Drug Compounding ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Lanham Act ,
Manufacturers ,
Orange Book ,
Outsourcing ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Pharmacies ,
Prescription Drugs ,
Statutory Violations
We have all been there: An advertisement on television or a pop-up on Facebook beckons us to try the latest “visit-free,” “delivered to your door” treatment for a medical condition.
Originally published in Dermatology Times...more
1/22/2020
/ Direct to Consumer Sales ,
Drug Compounding ,
E-Commerce ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Off-Label Promotion ,
Online Distribution ,
Online Platforms ,
Pharmaceutical Industry ,
Pharmacies ,
Popular ,
Prescription Drugs ,
Telemedicine
Patent protection can be critical for health care products, including medical devices, prescription drugs, dietary supplements and software as a medical device (SaMD).
Originally published in Law360 - September 8, 2017....more
FDA recently awarded new chemical entity (NCE) exclusivity to Austedo™ (deutetrabenazine). The Austedo approval is notable for two reasons: One, it is the first deuterated drug (i.e., a drug containing the stable isotope —...more
The prior approval of a drug containing an active ingredient of the innovator drug is not necessarily a death knell for NCE exclusivity.
Originally published in the Intellectual Property and Life Sciences sections of...more