Why was Viekira Pak discontinued?
This treatment has been discontinued. On October 22, 2015 the United States FDA issued a Drug Safety Warning that treatment with ombitasvir- Page 1/6 Page 2 paritaprevir-ritonavir and dasabuvir (Viekira Pak) can cause serious liver injury, mostly in patients with underlying advanced liver disease.
When was VIEKIRA approved?
Since VIEKIRA PAK's approval in 2014, AbbVie has supported access to medication for those living with chronic HCV and facing financial difficulties.
Why did the FDA approve ADUHELM?
In its written responses to The Times, the agency added that its decision took into account that patients expressed “their willingness to accept some uncertainty about clinical benefit to get earlier access to a potentially clinically valuable drug.”
When was Trijardy XR approved?
Development timeline for Trijardy XRDateArticleJan 27, 2020Approval FDA Approves Trijardy XR (empagliflozin/linagliptin/metformin) for Type 2 Diabetes in AdultsJan 28, 2021
When did FDA approve Qelbree?
The FDA has approved the supplemental new drug application for Qelbree (viloxazine) to treat adults with attention-deficit hyperactivity disorder (ADHD). It was approved in April 2021 to children 6 to 17 years of age. Greg Mattingly, M.D.
When did Winlevi get approved?
The first-in-class topical treatment for acne vulgaris, clascoterone (Winlevi, Sun Pharmaceuticals) cream 1%, has officially launched in the United States. The topical androgen receptor inhibitor was first approved by the FDA in August 2020 to treat patients 12 years and older who have acne vulgaris.
When did Fasenra get approved?
The FDA granted Orphan Drug Designation to Fasenra for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) in November 2018, hypereosinophilic syndrome (HES) in February 2019 and eosinophilic oesophagitis (EoE) in August 2019.
When did the FDA approve ADUHELM?
In the weeks following the FDA's approval of Biogen's aducanumab (Aduhelm) on June 7, 2021, the decision has been met with intense scrutiny and debate directed at nearly every level of the process.