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STAT+: FTC warns drugmakers they can face legal action over improper patent listings

STAT

In explaining its new policy statement , the FTC noted that some drug companies have failed to follow requirements for listing patents in the so-called Orange Book in hopes of thwarting competition from lower-cost generic medicines.

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FDA approves new ADHD and BED generics

Pharmafile

The US Food and Drug Administration (FDA) has announced that it has approved several first generics of Takeda’s Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets for attention-deficit/hyperactivity disorder (ADHD) in patients over the age of six years and for moderate-to-severe binge-eating disorder (BED) in adult patients.

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CHMP meeting highlights: April 2024

European Pharmaceutical Review

Last week, the US FDA approved a new gene therapy for eligible adults with haemophilia B. The committee also recommended the biosimilar medicine Wezenla (ustekinumab) to treat of plaque psoriasis. Generic medicine Eribulin Baxter (eribulin) was also granted a positive opinion by the committee, to treat breast cancer and liposarcoma.

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After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi

pharmaphorum

The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market. The post After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi appeared first on.

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STAT+: European regulator will review study data from contract research organization due to ‘serious concerns’

STAT

The review comes in response to an inspection of Synapse facilities by Spanish regulators, who raised “serious concerns about the validity and reliability” of clinical trial data generated by the company.

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US frets over pharma supply chain security

pharmaphorum

The pharmaceutical industry is no different, with India and China becoming two of the leading manufacturers and exporters of generic medicine, as well as medical supplies, antibiotics and ingredients required to manufacture treatments. By its own figures, the agency managed 61% of the planned inspections it had scheduled for 2020.

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Sertraline: Everything you need to know about generic Zoloft

The Checkup by Singlecare

Food Drug Administration (FDA) , a generic medicine works in the same way and provides the same clinical benefit as brand-name medicine. Generic medications must have the same dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. How much is generic Zoloft?