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

FDA Law Blog

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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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. It has however been contraindicated in people taking opioids.

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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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Top 40 Best-Selling Oncology Drugs in 2023 by 2022 Data

XTalks

This analysis not only highlights the financial success of these drugs but also sheds light on the therapeutic advancements and innovation driving patient outcomes in the oncology domain. Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data. Price of Revlimid: A supply of 28 oral 2.5

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FDA approves first interchangeable biosimilar insulin product for treatment of diabetes

The Pharma Data

The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution” – much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. Biosimilars marketed in the U.S.

Insulin 52
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In the News: October Regulatory and Development Updates

Camargo

When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.