Remove 2016 Remove FDA Approval Remove Pharmacokinetics
article thumbnail

Gepirone

New Drug Approvals

However, in 2012 it once again failed to convince the FDA of its qualities for treating anxiety and depression. [5] 5] In December 2015, the FDA once again gave gepirone a negative review for depression due to concerns of efficacy. [12] 12] However, in March 2016, the FDA reversed its decision and gave gepirone ER a positive review. [13]

FDA 62
article thumbnail

Metabolism of 2023 FDA Approved Small Molecules – PART 1

Metabolite Tales Blog

Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. link] [3] FDA prescribing information for daprodustat. Pharmacokinetics and Metabolism of Nirmatrelvir.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Landiolol

New Drug Approvals

Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDA APPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 April 2016). “Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics.

FDA 62
article thumbnail

FDA for approval to treat VTE and to prevent VTE in children

The Pharma Data

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. From November 2016 to June 2019, a total of 112 participants were enrolled across 36 sites in 10 countries. UNIVERSE was conducted in two parts.

FDA 52
article thumbnail

Dupixent® (dupilumab) pivotal trial meets all primary and secondary endpoints.

The Pharma Data

In 2016, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Dupixent for the treatment of severe atopic dermatitis (in children aged 6 months to 11 years of age). Detailed results from this trial will be presented at a future medical meeting, and data will be submitted to regulatory authorities.

Trials 52
article thumbnail

Advances in the Battle Against Autoimmune Disease

The Pharma Data

Under the terms of the amended agreement , originally executed in 2016 with Bristol Myers’ Celgene, an undisclosed fee was paid to Anokion to include KAN-101 for the treatment of celiac disease in the exclusive global collaboration. The secondary outcome involves pharmacokinetic endpoints. Receptor Inhibitors.

Disease 52
article thumbnail

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The committee also made recommendations regarding pharmacokinetic and safety assessments.

Science 40