FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target.

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Pharmacy Checkers

FEBRUARY 14, 2020

Finally, I put it together that this was related to the drug because when I wouldn’t take it I would begin to feel better. I have reported this to the FDA and will be seeing my doctor this week. So, what the heck happened with generic Budeprion XL? Not normal, but better. Wellbutrin XL 300mg sold at U.S.

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Branding FDA Approval Pharmacy Bioequivalency 62

The Pharma Data

MARCH 9, 2021

“This first-to-market generic version of AZOPT ® (brinzolamide ophthalmic suspension) 1% in the U.S. provides patients with another important treatment option,” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA. What should I tell my doctor before taking brinzolamide ophthalmic suspension 1%?

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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. Talk to your doctor if you are pregnant or plan to become pregnant.

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Pharmacy Checkers

JANUARY 10, 2020

This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. John’s doctor was skeptical of drugs bought online from other countries.

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FDA Law Blog

MAY 11, 2023

Agreeing with Judge Prost’s dissents in the Federal Circuit’s initial and rehearing decisions in this case, the Government argues that a generic’s labeling should not be treated as evidence of intent to induce infringement where that generic “plays by the rules of the section viii pathway” (internal citations omitted).

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Branding Generic Drugs FDA Approval Manufacturing 72

The Pharma Data

MARCH 7, 2022

“The launch of our first generic version of Revlimid® in the U.S. This product adds to our broad generic portfolio of oncology treatments, which accounts for 73% of the essential medicines in this category, as defined by the World Health Organization.”. Currently, 1 in 12 generic prescriptions dispensed in the U.S. About Teva.

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