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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

In Par and Novartis’ agreement, Par gained exclusive rights to market its generic for six months after Novartis’ period of exclusivity finished, beginning September 30, 2014 and ending March 30, 2015. Gilenya legal drama. Gilenya is an oral medication for multiple sclerosis.

Doctors 242
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When FDA-Approved Generics Fail: Brand Wellbutrin XL Antidepressant is Cheaper from Canada

Pharmacy Checkers

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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Can you trust Turkey-approved Alipza? Is it the same as U.S.-Approved Livalo?

Pharmacy Checkers

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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Teva Announces Launch of an Authorized Generic of Epiduo® Forte Gel (adapalene and benzoyl peroxide gel 0.3%/2.5%), in the U.S.

The Pharma Data

“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.

Doctors 52
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Hitting Pause on Criticism of the FDA, Just for Today

Pharmacy Checkers

The FDA’s capacity to evaluate new and generic drug applications and its oversight over drug manufacturing are why we have this degree of assurance. This is the heart of FDA’s mission. I have summarized the main FDA roles, as carried out by CEDR and ORA, in protecting the U.S. drug supply.

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FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

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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First Generic Version of AZOPT® (brinzolamide ophthalmic suspension) 1%, used to treat high pressure inside the eye

The Pharma Data

“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%?

Doctors 52