Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. The FDA nod means Rinvoq is now approved for seven indications in gastroenterology, rheumatology and dermatology.

Mayo Clinic 105

Mayo Clinic Dosage FDA Immunization 105

The FDA Law Blog

OCTOBER 12, 2023

Koblitz — For years, submitting a Suitability Petition has been like screaming into a void: You’d be lucky if FDA ever responds. This has been a big problem because FDA’s inattentiveness can delay entry of certain types of ANDAs for years—often resulting in the ANDA applicant’s abandonment of the Suitability Petition. Under 21 C.F.R.

FDA 59

FDA Dosage 59

The Checkup by Singlecare

MARCH 21, 2024

The drug and its fellow SGLT2 inhibitors, Farxiga (dapagliflozin), Invokana (canagliflozin), Steglatro (ertugliflozin), and Brenzavvy (bexagliflozin), are approved by the Food and Drug Administration (FDA) for treatment of Type 2 diabetes. Although there is no generic version of Jardiance available currently, there may be as early as 2025.

Insurance 98

Insurance Adverse Reactions FDA Dosage 98

Pharmaceutical Technology

SEPTEMBER 22, 2022

In 2021, the WHO and the United Nations announced a plan to reduce premature mortality related to noncommunicable diseases, including cardiovascular disease, by 25% leading up to 2025. In 2013, the FDA first approved Vazkepa solely for the reduction of triglyceride levels for hypertriglyceridemia. Amarin’s net product revenue was $577.9

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies FDA Dosage 52

Pharmaceutical Technology

JULY 29, 2022

This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned. The EMA started a rolling review for this Omicron-adapted vaccine on 27 June and the FDA plans to review the vaccine for EUA. 1 sub-lineage on 19 July.

Vaccines 52

Vaccines Packaging Immunization FDA 52

The Checkup by Singlecare

NOVEMBER 29, 2022

Namzaric is a prescription combination drug FDA approved to treat moderate to severe dementia due to Alzheimer’s disease. Unfortunately, there are no generic versions of extended-release memantine/donepezil, and there won’t be until 2025. Is Namzaric covered by insurance? | How much does Namzaric cost without insurance? |

Insurance 52

Insurance Insurance Coverage Dosage FDA 52

ISPE

SEPTEMBER 11, 2023

POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms.” FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” Journal of Biotechnology 213 (2015):120–30. doi:10.1016/j.jbiotec.2015.06.388

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52