03
Mar
Businessman Looking At The End Of The Road

FDA Determination that Lorcaserin Was Withdrawn for Safety Reasons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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02
Mar

After Two FDRR, FDA Set to Issue Refusal to Approve NDA for Sotagliflozin Oral Tablets

In a prepublication of a Federal Register notice (here) that will publish on March 3, 2021, the FDA has announced its intention to refuse to approve the 505(b)(1) NDA originally filed by Sanofi and now held by Lexicon Pharmaceuticals for Sotagliflozin Oral Tablets, 200 mg and 400 mg.  The product was intended to be indicated […]

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05
Feb

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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13
Jan

Statutes and Regulation Verses Reality – Is Transparency the Key?

While reading a blog post by Michael Mezher of RAPS this morning, entitled HHS Pushes Through Last-Minute Policies Impacting FDA (here), it struck me that my own age old question is almost (and I stress almost) being addressed.  The question is, when a regulation or statute directs the FDA to meet certain review timeline requirements, […]

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22
Dec
CHANGES AHEAD: Roadside sign: Trailer mobile warning sign parked by road with words for safety by orange cones

Important – Facility Inspection Impact on Applications, Amendments, Resubmissions and Supplements

FDA’s ability to conduct on-site inspections has been significantly impacted by the COVID-19 pandemic.  While the FDA is looking and utilizing alternate methods to conduct such inspections when needed, some of the alternate methods are, at least, as time-consuming as actual on-site inspections.  Because of this issue and the Agency’s goal of being transparent, they […]

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15
Oct

Extension Sought on Comments Regarding Patent Listing

On June 1, 2020, in Docket FDA-2020-N-1127 and published in the Federal Register, the Agency asked for public comment regarding updating and clarifying the types of patents that could be listed in the Orange Book (here).  The document sought comments on two specific issues of continued interest: should patents be submitted to the FDA and […]

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07
Oct

Are ADHD/Stimulant Drugs Dropping Off the FDA’s ADF Radar?

This morning, in reading an article from the Pink Sheet written by Sarah Karlin-Smith, I flashed on my blog post from September 24, 2020 (here) discussing the new warning on benzodiazepine products.  In this post, I had expressed concern that the abuse-deterrent formulation (ADF) craze of opioid formulations might be creeping in on other products […]

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24
Sep

Benzodiazepine Boxed Warning Update, a Harbinger of Things to Come?

In a drug safety communication on September 23, 2020 titled FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class (here), the FDA announced changes being made to the boxed warning on all benzodiazepine products.  The communication describes the need for the change as follows: “[T]o address the serious risks of abuse, […]

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