Ever See a PANDA In Real Life?  Of Course You Did – You May Even Own One!

In today’s prepublication of the Federal Register listing (here), there is a notice asking for stakeholder comments on the treatment of pre-1962 applications approved as ANDAs that were actually (unbeknownst to most) submitted under section 505(b) of the Act and approved under section 505(c) of the Act, like an NDA.  The historical issues leading to […]

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Doctor holding a clipboard with Safety first, Medical concept

Changes to the Clozapine REMS will Take Effect on November 15, 2021 – Be Prepared

Clozapine was one of the first drugs to have a “REMS” system in place to ensure safe use such that patients developing clozapine-induced severe neutropenia were precluded from getting the drug, which would do further damage, and, thus, avoiding potentially life-threatening scenarios. Initially, the REMS program was independently operated by the innovator and, once the […]

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FDA Determination that Lorcaserin Was Withdrawn for Safety Reasons

On January 14, 2020, we posted a blog (here) concerning a Drug Safety Communication discussing FDA’s concern that the drug product Belviq or Belviq XR (lorcaserin) could increase the risk of cancer.  On September 16, 2020, we posted a blog noting FDA’s final action withdrawing the 2 NDA drug applications for the product mentioned above […]

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Safety Trial Finds Increased Risk of Serious Heart-Related Problems and Cancer with Xeljanz, Xeljanz XR (tofacitinib)

When FDA approved the Pfizer drug product tofacitinib (Xeljanz, Xeljanz XR), which treats arthritis and ulcerative colitis by decreasing the activity of the immune system, they required that Pfizer conduct post-approval safety trials to evaluate the risk of serious heart-related events, cancer and infections. Tofacitinib is offered in two strengths which were both studied in […]

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Outlining COVID-19 Safety Expectations for ANDA BE Studies

On January 15, 2021, the FDA issued the guidance titled “Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency”.  This guidance provides recommendations to study sponsors for the continuation or initiation of their bioequivalence (BE) studies during this COVID-19 public health emergency.  As is no surprise, FDA clearly […]

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Weight Loss Drug Voluntarily Withdrawn for Apparent Safety Reasons

The Food and Drug Administration (FDA) is taking final official action withdrawing the approval of two new drug applications for BELVIQ (lorcaserin hydrochloride (HCl)) tablets and BELVIQ XR (lorcaserin HCl) extended-release tablets which were originally approved by FDA on June 27, 2012 and July 15, 2016, respectively.  This announcement was made on the Federal Register’s […]

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Just When you Thought it Was Safe to Come out of the Compounding Hood: Apparent Dearth of Evidence for the Effectiveness & Safety of Compounded Bioidentical Hormone Therapy

In late 2018, FDA entered a contract with the National Academies of Sciences, Engineering, and Medicine (the National Academies) to examine the clinical utility (effectiveness), safety and uses of compounded bioidentical hormone therapy (cBHT).  A high-level committee was formed and examined in detail the clinical utility of cBHT drug preparations, especially those containing estradiol, estrone, […]

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REMS – Revision 2 Adds Updates to Previous Two Versions

The FDA released an updated version of its Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry as Revision 2.  Originally issued in 2015 (here) and updated again in 2019, the June 2020 version contains much the same information but provides updates as to timetables, additional categories of PAS, CBE, and CBE 30 […]

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Sometimes you get what you pay for; FDA joins forces with India to halt illicit drug sales

The United States Food and Drug Administration and the Indian Government join forces in “Operation Broadsword”.  No, it’s not a trailer for an action thriller, it’s a serious collaboration between two governmental entities to limit the import and sale of illicit drugs to consumers, detailed in FDA’s news release on February 18, 2020 (here). The […]

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