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STAT+: FDA cites Granules, a large Indian generic drug manufacturer, for tossing truckloads of key documents

STAT

Amid ongoing concern over the quality of medicines made in India, a major supplier of generic medicines was seen removing three truckloads of “scrap materials” from a facility that was being inspected last month by the Food and Drug Administration.

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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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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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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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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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Astellas loses bid to block Lexiscan generics in US

pharmaphorum

It looks like Astellas has been unsuccessful in its attempt to block Pfizer’s generic medicines unit Hospira from launching a copycat version of big-selling pharmacologic stress agent Lexiscan in the US. Hospira isn’t the only generics company trying to bring a version of regadenoson to the US market.

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Astellas facing generics to big-selling Lexiscan product in US

pharmaphorum

Astellas has won a reprieve in its attempt to stop Pfizer’s generic medicines unit Hospira launching a copycat version of its pharmacologic stress agent Lexiscan in the US – but only for a couple of weeks. ” Hospira isn’t the only generics company trying to bring a version of regadenoson to the US market.