FDA Approvals

Date Posted
Article Title
11/26/2019
FDA Approves First System to Insert Ear Tubes Under Local Anesthesia

Success rates of 86 and 89 percent reported for children <5, 5 to 12 years, respectively

11/26/2019
FDA Approves Oxbryta for Treatment of Sickle Cell Disease

Drug is first approved treatment that directly inhibits sickle hemoglobin polymerization

11/25/2019
FDA Approves XCOPRI for Treatment of Partial-Onset Seizures

Versus placebo, percent of seizures per 28 days reduced with 100-, 200-, 400-mg doses of XCOPRI

11/22/2019
Givlaari Approved for Acute Hepatic Porphyria

Subcutaneous injection once monthly aims to help reduce the number of porphyria attacks

11/22/2019
Calquence Approved to Treat CLL, SLL

Progression free-survival longer with Calquence versus other standard treatments

11/18/2019
Brukinsa Approved for Relapsed, Refractory Mantle Cell Lymphoma

Two clinical trials showed tumor shrinkage in 84 percent of patients

11/18/2019
11/15/2019
Fetroja Approved to Treat Complicated Urinary Tract Infections

Label warns higher mortality found in critically ill patients with multidrug-resistant Gram-negative bacterial infections

11/13/2019
Reblozyl Approved to Treat Anemia in Patients With Beta Thalassemia

Drug is first therapy approved to help reduce number of blood transfusions

10/11/2019
FDA Approves Reyvow for Acute Migraine

In clinical trials, pain resolved at two hours in significantly more patients taking Reyvow versus placebo

10/9/2019
Implant Approved for Patients With Phototoxic Reactions From Rare Disorder

Scenesse increases pain-free light exposure in patients with erythropoietic protoporphyria

10/4/2019
FDA Approves Descovy for HIV-1 Preexposure Prophylaxis

Drug indicated to reduce risk for HIV-1 infection from sex excluding receptive vaginal sex

10/1/2019
Rituxan Approved for Pediatric Patients With Rare Vasculitis Diseases

Approval of Rituxan expanded to children with granulomatosis with polyangiitis, microscopic polyangiitis

9/30/2019
Mavyret Approved as 8-Week Treatment for Hep C, Compensated Cirrhosis

Drug approval expanded to any treatment-naive HCV patients, regardless of cirrhosis status or treatment type

9/26/2019
FDA Approves Vaccine for Prevention of Smallpox, Monkeypox

Jynneos is approved for adults considered at high risk for infection

9/9/2019
FDA Approves First Treatment for ILD With Systemic Sclerosis, Scleroderma

Approval of Ofev for this indication based on data from SENSCIS study

8/28/2019
Nourianz Approved to Treat 'Off' Episodes in Parkinson Disease

Drug showed efficacy as add-on treatment for 'off' episodes in PD patients taking levodopa/carbidopa

8/19/2019
New Antibiotic Approved for Community-Acquired Bacterial Pneumonia

Clinical data show similar results between Xenleta and moxifloxacin with or without linezolid

8/19/2019
Implant Approved to Improve Symptoms in Advanced Heart Failure

Barostim Neo System indicated for patients not suited for cardiac resynchronization therapy

8/19/2019
Rozlytrek Approved to Treat Tumors With NTRK Gene Fusion

Drug also approved to treat metastatic non-small cell lung cancer with ROS1-positive tumors