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FDA Approves Generics of Takeda’s ADHD, Binge Eating Drug Vyvanse

BioSpace

Amid a supply shortage of the attention-deficit/hyperactivity disorder and binge-eating disorder medication, the regulator has cleared a slew of generic drugs of Takeda’s Vyvanse pill.

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Generic Drugs Approved but not Launched – How to Tell When Generic Drugs Will hit the Market

Drug Patent Watch

Just because a drug has received FDA approval does not mean that it is available in the marketplace. The post Generic Drugs Approved but not Launched – How to Tell When Generic Drugs Will hit the Market appeared first on DrugPatentWatch - Make Better Decisions.

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Faster FDA Approvals Don’t Affect Generic Drug Availability or Cost

Pharmacy Checkers

I’m proud to share that PharmacyChecker has published a white paper that examines prices and availability of newly approved generic drugs. Out of 40 generic medications that were approved from 2017 to 2018, PharmacyChecker research found the following: 42.5% (17) are not available in the U.S. generic versions.

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FDA Sort-of Commits to Meet with Generic Drug Manufacturers that Have Received Warning Letters

FDA Law Blog

Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S. Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility.

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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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FDA Approves First Generic of Symbicort to Treat Asthma and COPD

The Pharma Data

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.

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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.