01
Apr

80 Products Approved with CGT Designation Thus Far

The FDA has released its most current list of Competitive Generic Therapy (CGT) ANDA approvals (here).  CGT-designated products (products for which there is little, if any, generic approvals for NDA products) may be eligible to receive 180-days of market exclusivity from a subsequent ANDA approval for the same strength and product. After any ANDA approval […]

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23
Mar
Female manager showing stop sign to arguing workers office, conflict resolution

FDA Reviews 20 Drug Products and Determines that They Were Not Discontinued for S&E Reasons

Once an approved NDA product is discontinued from marketing or withdrawn, the FDA must make a determination that the reason for such action by the innovator was not for safety or efficacy reasons (see 21 CFR 314.161(a)).  Such a determination must be made before an ANDA for a duplicate of the reference listed drug (RLD) […]

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17
Mar
Rough roadway

Update on Meeting CDER User Fee Goals During Pandemic – Not Too Bad!

As we all know, the pandemic has wreaked havoc with inspections of drug manufacturers, API manufacturers, and laboratory facilities, as well as inspection of clinical study sites.  Remote working, meeting problems, and just general pandemic fatigue has hindered some of the FDA’s work.  However, the statistics are not as bad as one might think, all […]

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16
Mar

Milligram Equivalents of Morphine – What is This About?

For those of you that are not directly in the pharmaceutical industry or who are not healthcare providers, you may wonder why the FDA is having a meeting to discuss the morphine milligram equivalents for other opioids.  Well, I know that measure gives healthcare providers a good idea of how to transition patients taking morphine […]

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08
Mar
Business approvals

Preview of OGD February 2021 Approval Actions

The unofficial approval-action numbers for ANDAs improved a bit from last month’s seventy, with the OGD hitting a total of full- and tentative-approval actions of seventy-eight.  This breaks down to seventy‑two full-approval actions and six tentative-approval actions.  These numbers are as of the morning of March 5, 2021 from the FDA’s All Approvals list (here). […]

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05
Mar
Mothers of preschoolers

FDA Updates January 2021 Statistics – Are Both the Industry and FDA Experiencing a Slowdown?

The Office of Generic Drugs updated its Generic Drugs Program Activities Report – Monthly Performance for January (here) to fill in more data on various metrics.  As you know, the Agency typically comes out with the number of ANDA approval and tentative-approval actions and receipts of original ANDAs, along with the number of complete response […]

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05
Mar
Vials

Vial and Component Relief from the FDA for the Vile component Shortage Created by the Pandemic

FDA has proposed some relief from the component shortages created for parenteral and other products identified in the just released Guidance entitled, COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers. The Agency has recognized the need to provide some regulatory flexibility regarding the filing type for certain changes that may be necessitated […]

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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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