FDA Law Blog

SEPTEMBER 6, 2023

Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S. Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility.

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Pharmacy Checkers

FEBRUARY 14, 2020

Of our most merciful health insurance companies, few are willing to cough up the cost of expensive brand meds when there’s an FDA-approved generic on the market. Despite the small but mighty uproar on lack of true generic equivalence, this is the case with Wellbutrin. Wellbutrin XL 300mg sold at U.S. Below are U.S.

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Camargo

OCTOBER 14, 2021

The pilot program is the first step in allowing manufacturers to receive a preliminary review of a novel excipient, prior to drug product formulation. Eligibility for the pilot program has been limited to excipients that 1) have not been previously used in FDA-approved drug products, and 2) do not have an established use in food.

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Camargo

DECEMBER 9, 2020

If you are facing an FDA remote review, Camargo can help design a comprehensive approach in order to avoid such pitfalls. Approval of the Month: Alnylam to Use Value-Based Agreements for Ultra-rare Disease Treatment. Unapproved Drug Initiative Ends. In November, the FDA ended its Unapproved Drug Initiative.

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FDA Law Blog

AUGUST 17, 2023

Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § 355(j)(2)(A)(v).

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The Pharma Data

MAY 17, 2021

These initiatives could support insurance coverage of previously off-label uses, prevent costly new drugs from inappropriately receiving preferential regulatory treatment that is intended for drugs with no FDA-approved alternatives, and better inform clinicians by providing evidence-based information about how drugs should be used,” they noted. .

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Pharmacy Checkers

JANUARY 10, 2020

This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. That word “same” is hard to answer when it comes to prescription drugs.

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