Drug Delivery, FDA Approval, Generic Drugs and Marketing

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Update: FDA clears first generic of AZ’s blockbuster Symbicort

pharmaphorum

MARCH 16, 2022

Viatris (formerly Mylan) has become the first drugmaker to win full FDA approval for a generic version of AstraZeneca’s top-selling respiratory drug Symbicort, although launch plans remain uncertain for now. Generics of Symbicort are already available in some non-US markets, including in Europe.

FDA Approval

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To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

FDA Law Blog

SEPTEMBER 19, 2023

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. The FTC notes in its Press Release that FDA supports the FTC Policy Statement, but there’s no further discussion of FDA’s role here.

Drugs

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Clinical Research Informer

Update: FDA clears first generic of AZ’s blockbuster Symbicort

To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

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