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Labetalol batch recalled due to wrong dosage labelling

The Pharmacist

But the Medicines Healthcare Products Regulatory Agency (MHRA) said that the actual tablets were 200g strength, consistent with the information on the outside of the box. Pharmacists have been instructed to immediately stop […] The post Labetalol batch recalled due to wrong dosage labelling appeared first on The Pharmacist.

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Edible sensor delivers real-time antiretroviral dosage data

European Pharmaceutical Review

An innovative ingestible sensor technology tested in an interventional clinical trial provided HIV patients with real-time antiretroviral dosage data , enabling them to better control their infection. Participants were recruited from HIV clinics in the US, randomised 1:1 to either an (information system) IS or usual care (UC) group.

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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new. What is drug dose optimisation?

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The Comprehensive Science and Art of Pharmaceutical Drug Naming

Drug Patent Watch

Pharmaceutical drug names are more than just a label - they're a carefully crafted code that conveys essential information about the medication. From the prefix that indicates the type of active ingredient to the suffix that signals the dosage form, every letter and symbol has a specific meaning.

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The Science Behind Generic Drug Bioequivalence

Drug Patent Watch

The Science Behind Generic Drug Bioequivalence: Separating Fact from Fiction As a healthcare professional or someone simply looking to stay informed, you've likely heard the term "bioequivalence" thrown around when it comes to generic drugs. But what does it really mean, and how does it impact the medications we take?

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Biocon acquires manufacturing facility of Eywa Pharma

Express Pharma

Biocon recently announced that its step-down, wholly-owned subsidiary, Biocon Generics has acquired Eywa Pharma’s oral solid dosage manufacturing facility, located in Cranbury, New Jersey, US, effective September 1, 2023. A company statement informed, “The facility is acquired for a total consideration of $7.7

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To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

FDA Law Blog: Biosimilars

Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. The bill proposes to amend FDC Act § 505(b) and PHS Act § 351(a)(2) with respect to patent information submitted to FDA for Orange Book and Purple Book listing. Koblitz & Kurt R.