article thumbnail

Scrub-a-Dub-Dub: FTC is Cleansing the Orange Book of Device Patents

The FDA Law Blog

Citing to a 2004 Supreme Court case, Verizon Commc’ns., 398 (2004), Teva argued that Amneal has no cause of action under antitrust law because the Hatch-Waxman Amendments impose a new statutory duty on a company to cooperate with competitors and established a remedy for breach of that obligation. of Trinko, LLP , 540 U.S.

Dosage 116
article thumbnail

Cymbalta generic availability, cost, and dosage

The Checkup by Singlecare

Food and Drug Administration (FDA) in 2004 , Cymbalta has become a widely used antidepressant to treat various mental health and pain-related conditions. The post Cymbalta generic availability, cost, and dosage appeared first on The Checkup. It is also approved for fibromyalgia and chronic muscle pain. Approved by the U.S.

Dosage 52
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance). Future outlook.

article thumbnail

Happy 40th Anniversary Hatch-Waxman! We’re Celebrating By Providing Access to a New Archive

The FDA Law Blog

1999P-2778) “request[ing] FDA disclose to the public through its Web site (1) the name of the innovator drug and approved dosage strengths, (2) the date the first Paragraph IV-containing ANDA is submitted, and (3) the dosage strengths included in that ANDA.” On October 4, 2000, a second Citizen Petition (FDA Legacy Docket No.

FDA 59
article thumbnail

Can you take Excedrin and ibuprofen together?

The Checkup by Singlecare

If you are taking other medications containing acetaminophen, you’ll need to calculate your total daily dosage when taking Excedrin to ensure you’re not overmedicating. How to take Excedrin with ibuprofen Generally, you shouldn’t take ibuprofen and Excedrin together.

Dosage 52
article thumbnail

Computed tomography for in-depth investigation of freeze-dried products

European Pharmaceutical Review

X-ray technology is also increasingly used in pharmaceutical R&D, particularly for examining solid dosage forms, an application for which this technology can be seamlessly adopted. Int J Pharm 2004; 271(1-2): 215–24 [[link] 15129988] 2. X-ray Microtomography of Solid Dosage Forms. Sinka IC, Burch SF, Tweed JH, Cunningham JC.

Dosage 98
article thumbnail

ISPE Communities of Practice Leaders – Nik Krpan

ISPE

Some recent projects include upgrading a biologics manufacturing process facility and expanding manufacturing capabilities at an oral solid dosage facility. Nik has been a member of ISPE since 2004. Based in Canada, Cheme Engineering oversees projects from all over the world primarily in the biotech and pharma industry.