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FTC Continues to Rage Against Device Patent Listings in the Orange Book

The FDA Law Blog

Koblitz — The FTC appears to be on a mission to cleanse the Orange Book of patents it deems improperly listed. For the second time in recent years, the FTC has filed an Amicus Brief explaining exactly which patents should not be in the Orange Book. Because a “drug product” is defined by regulation as a “Finished dosage form.

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Abilify generic availability, cost, and dosage

The Checkup by Singlecare

Dosage forms Brand-name and generic Abilify are prescribed at the same dosage and frequency. Generic drugs must be the same as brand-name medications in dosage, safety, effectiveness, strength, stability, quality, and how it is taken. mL, 960 mg/3.2 mL, 960 mg/3.2 Then, find a local pharmacy that accepts SingleCare coupons.

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Drugs Companies Clap Back at Congress…Then Get Sued

The FDA Law Blog

Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately. Rather, the FTC questioned whether these patents meet the statutory and regulatory criteria for listing in the Orange Book.

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To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

The FDA Law Blog

Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. Last week, the FTC held a Listening Session about the listing of patents in the Orange Book, which concluded with a unanimous vote to issue a Policy Statement.

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The Streams Have Been Crossed: FTC Enters FDA Territory

The FDA Law Blog

” At least that’s this blogger’s reaction to the recent news that FTC sent out Notice letters to 10 different drug companies about the patent information they list in the Orange Book. As FTC explains in a Press Release , the Agency “challenged more than 100 patents” that it believes are improperly or inaccurately listed in the Orange Book.

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Does Lexapro make you tired?

The Checkup by Singlecare

Ask about changing the dosage or your medication Prolonged fatigue when taking Lexapro could be a sign that your dose is too low (and not alleviating symptoms of depression) or too high (leading to side effects). Don’t adjust the dosage on your own or stop taking the medication without medical advice. appeared first on The Checkup.

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FDA Knows Its Own Strength—and It Includes Concentration

The FDA Law Blog

314.3 , codified in 2016, which defines strength as the “ total quantity of drug substance in mass or units of activity in a dosage unit or container closure” and/or “the concentration of the drug substance.” solid oral dosage forms),” which, FDA posits, suggests “that the terms have overlapping meanings.”

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