FDA Law Blog

JUNE 28, 2023

1844 – Animal Drug and Animal Generic Drug User Fee Amendments of 2023. The proposed legislation appears to be an effort to resolve issues created by FDA’s Center for Veterinary Medicine’s (CVM) interpretation of the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of food.

Regulation 45

Regulation Drugs Production Generic Drugs 45

pharmaphorum

JULY 29, 2021

Advanz hiked the price of a pack of liothyronine tablets – used to treat thyroid hormone deficiency – from £20 in 2009 to £248 in 2017, taking advantage of a lack of competition for the drug even though it was out of patent. ” Advanz itself was directly fined £40.9 million and £51.9 million, respectively. .”

Drugs 98

Drugs Marketing Generic Drugs Hormones 98

pharmaphorum

AUGUST 28, 2020

An androgen receptor inhibitor, Winlevi (clascoterone) has been cleared by the US regulator for the treatment of acne in patients 12 years and older and is due to be launched early next year, according to the company. Retinoids can help unclog pores, while antibiotics can limit the growth of bacteria.

Dermatology 52

Dermatology Drugs Hormones FDA Approval 52

XTalks

FEBRUARY 5, 2024

Sandostatin (Octreotide) Sandostatin 2022 sales: $1.238 billion Company/Developer: Novartis Date of first FDA approval: October 21, 1988 Indications Sandostatin is FDA-approved for: Sandostatin is a synthetic protein closely resembling the natural hormone somatostatin in the human body. million the drug made during the same time in 2022.

FDA Approval 101

FDA Approval Drugs Sales Development 101

XTalks

FEBRUARY 5, 2024

Sandostatin (Octreotide) Sandostatin 2022 sales: $1.238 billion Company/Developer: Novartis Date of first FDA approval: October 21, 1988 Indications Sandostatin is FDA-approved for: Sandostatin is a synthetic protein closely resembling the natural hormone somatostatin in the human body. million the drug made during the same time in 2022.

FDA Approval 52

FDA Approval Drugs Sales Development 52

XTalks

AUGUST 2, 2023

5) Ibrance (palbociclib) Ibrance is a chemotherapy drug indicated for hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. It is a CDK 4/6 inhibitor that is taken in combination with other hormonal therapies to stop the growth of cancer and healthy cells.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

MAY 4, 2021

announced that the EMA has validated for review the MAA for somatrogon, a long-acting recombinant human growth hormone intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency. Somatrogon — In February 2021, Pfizer and OPKO Health Inc.

Vaccination 40

Vaccination Vaccine Production Sales 40