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In the News: October Regulatory and Development Updates

Camargo

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

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Buscopan vs Mebeverine | OTC IBS treatment

Druggist

Mebeverine, on the other hand, is a generic name of the drug, which is also known as Colofac (brand name). Both products contain the same active ingredients regardless of whether they are prescribed or purchased over the counter: Each Buscopan tablets contains 10mg of hyoscine butylbromide.

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NOW AVAILABLE: The 2022 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

Drug Channels

Twice a year, I research and write two comprehensive, fact-based, and nonpartisan reports on drug channel economics. The 12 chapters are self-contained and do not need to be read in order. In some small way, I try to make the world a better and smarter place.

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FDA Knows Its Own Strength—and It Includes Concentration

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.” mg/mL) for liquid parenteral drug products. FDA borrowed this definition from 21 C.F.R.

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Lymecycline for ACNE: Questions & Answers

Druggist

Lymecycline is usually prescribed as a generic drug – lymecycline 408mg capsules or occasionally as a branded medication called Tetralysal 300 mg capsules. Both drugs are the same medicines. Although licensed for acne, minocycline is rarely prescribed in the UK. How does lymecycline work for acne?

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TLC Provides Corporate Update at Investor Conference – Dec 18, 2020

The Pharma Data

With experiences attained in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, Mr. Bliss introduced himself in Mandarin Chinese. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. SOUTH SAN FRANCISCO, Calif.

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Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir. In 2022, Biktarvy generated $10.39 In 2022, Xgeva generated $2.01 Pfizer’s total global revenue from Paxlovid was $18.93

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