The Pharma Data

DECEMBER 4, 2021

” With nearly 550 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market, and holds the leading position in first-to-file opportunities, with approximately 100 pending first-to-files in the U.S. Currently, 1 in 11 generic prescriptions dispensed in the U.S.

Doctors 52

Doctors Doctor Medicine Production 52

Advarra

JULY 19, 2022

The sponsor-initiated IND is conducted by a pharma company seeking commercial approval. Q: When you want to do a study of an FDA-approved drug under an investigational indication, is an IND still required or can you seek an exemption? A: It depends, but the answer is usually yes. Q: What is the definition of a drug?

Packaging 52

Packaging Packaging Drugs Containment 52

Pharmacy Checkers

NOVEMBER 21, 2019

Wikipedia has an extremely long page aptly called Criticism of the Food and Drug Administration , much of it having to do with its role with prescription drugs, and less so other sectors, such as food, tobacco and cosmetics. . I have summarized the main FDA roles, as carried out by CEDR and ORA, in protecting the U.S. drug supply.

Generic Drugs 68

Generic Drugs Manufacturing Drugs Regulation 68

FDA Law Blog

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.

Production 59

Production Drugs FDA Approval Compliance 59

The Pharma Data

MARCH 15, 2022

This drug-device combination product is a metered-dose inhaler (MDI), which contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing). Source link: [link] ov/.

FDA Approval 52

FDA Approval Generic Drugs Production Drugs 52

FDA Law Blog

JANUARY 18, 2024

Rescheduling Analyses, 2016 DEA noted in 2016 that a drug had a currently accepted medical use for purposes of the CSA if it was the subject of an approved new drug application (“NDA”) under the Federal Food, Drug and Cosmetic Act. 21 U.S.C. § 802(16)(B). chemotherapy-induced), pain, and post-traumatic stress disorder.

Drugs 69

Drugs FDA Approval Containment Production 69

FDA Law Blog

MARCH 13, 2024

Part 2 (“Part Deux”) investigated the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise). Do you really have to identify both “Grants” to be correct?

Marketing 59

Marketing Production FDA Approval Generic Drugs 59

The Pharma Data

DECEMBER 18, 2020

In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information. The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. SOURCE U.S. Food and Drug Administration.

Vaccination 52

Vaccination Vaccine Production Manufacturing 52

XTalks

AUGUST 2, 2023

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 addition, the FDA approved Pfizer’s pneumococcal 20-valent conjugate vaccine, Prevnar 20, for the first time in June 2021.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

NOVEMBER 29, 2021

The use of folate, folic acid, or folate-containing supplements should be avoided within 48 hours before administration of Cytalux. The FDA previously granted Cytalux orphan-drug , priority and fast track designations. The FDA granted the approval to On Target Laboratories, LLC. The FDA, an agency within the U.S.

FDA Approval 52

FDA Approval Drugs Protein Cosmetics 52

FDA Law Blog

JANUARY 8, 2025

Because ProAir HFA contains features claimed by the patentthe dose counter and canisterTeva argued that its patents were properly listed in the Orange Book. Teva also argued that the Federal Food, Drug, and Cosmetic Acts definition of drug includes the device component.

Production 111

Production Drugs Cosmetics FDA Approval 111

Pharmacy Checkers

DECEMBER 20, 2019

The agency drafted a new proposed rule to allow importation from Canada of lower-cost drugs and industry guidance for drug manufacturers to import their FDA-approved foreign drug versions, for which they can charge lower prices. And can’t they already import FDA-approved drugs? Well, apparently it can be done.

Drugs 73

Drugs FDA Approval Cosmetics Pharmacy 73