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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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What happened to all the antibiotics?

pharmaphorum

Moreover, more than any other medicine, antibiotics are more likely to face insufficient supply, with analysis by the US Pharmacopeia suggesting they are 42% more likely to be in shortage compared to all other drugs. Larger questions remain around the way in which to support manufacturers to invest in production capabilities for antibiotics.

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Pathbreakers: The journey of first generics

Pharmaceutical Technology

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. These medicines comprise about 10% of all generics approved each year. Still, the FDA does prioritize the review of submissions for first generics.

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