Petition Requests Removal of Generic Tasimelteon from the Market for Lack of Braille on Its Label

This is something I have not come across in over fifty years in the pharmacy and pharmaceutical business!  The issue is related to a drug product called Hetlioz (tasimelteon) capsules, marketed by Vanda.  The product is indicated for non‑24‑hour sleep‑wake disorder (non‑24) and nighttime sleep disturbances in Smith‑Magenis Syndrome (SMS) in children and adults.  The […]

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Oncology Drugs and Cross Labeling – An Important Document – But Hurdles May Still Exist

Today the FDA issued a guidance entitled Cross Labeling Oncology Drugs in Combination Regimens ( that describes the Agency thinking on cross labeling of oncology drugs for which there is a proven benefit from their combined use.  As I read the guidance a few things popped into my mind. How can one firm who owns […]

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Here We Go Again! Virginia Rep. McEachin Does Not Get It!

Congressman A. Donald McEachin (VA-04) comments “Today, [I] introduced the Updated Drug Labeling for Patient Safety Act, legislation to direct the Food and Drug Administration (FDA) to allow generic drug manufacturers to update their product labeling with safety-related information.” (see here). He notes that “[T]he Updated Drug Labeling for Patient Safety Act is commonsense legislation […]

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It’s Elementary – FDA Guidance for Na, K, and P Labeling for Rx and OTC Products

Published a few days ago, the FDA draft guidance titled Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products (here) discusses the FDA’s thinking on the standardization, proper format, and necessary information for the contents of these elements in OTC and prescription drug labeling.  Right now, labeling for OTC products […]

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Two Numbers From 10 to 12 – What a Difference It Can Make!

For years, the FDA has been concerned about running out of numbers for the National Drug Code (NDC) to use to identify drug products. They estimate that their runway for exhausting all NDC number combinations may come in 10-15 years. Well, FDA published a proposed rule entitled Revising the National Drug Code Format and Drug […]

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Have Some Time?  Read FDA’s Expectations on How to Assure Drug Product Labeling Is Safe!

You may need some time to read this recently published guidance entitled, Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (here), as it is 41 pages long. There is lots of good information contained in the document and, while it may contain most of what you know about labeling requirements, […]

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Skinny Label Is Still Losing Weight – Can It Survive or Will It Starve to Death?

In previous posts here and here, we outlined the attack on the carveout provisions of the Hatch-Waxman Act (also lovingly known as the “skinny label”) that the crafters of the Act included to ensure that generic drugs could get to consumers if there were certain patents or exclusivity issues that would otherwise block entry into […]

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Don’t Get a Swelled Head, Feeding Tube Guidance Straightens Out Requirements

Today, the FDA released its draft guidance entitled Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations Guidance for Industry (here). There have been numerous cases of clogging or otherwise blocking of enteral naso-gastric (N-G) feeding tubes when medication is administered due to a number of different reasons:  swelling of […]

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