U.S. Regulatory News May 2019

reg-news-2019


News of FDA orphan drug, priority review, and approvals for humans and animals.

Source: Bloomberg BNA (reports from March 11 and 18, 2019) and the Food and Drug Administration website. Compiled by Linda C. Brown, managing editor.

HUMAN |
ANIMAL

 

HUMAN

Company Trade Name Generic Name Action

Acceleron Pharma Inc.

ACE-083

FDA granted orphan drug designation for the treatment of patients with Charcot-Marie-Tooth disease.

Aerie Pharmaceuticals Inc.

Rocklatan

FDA approved Rocklatan for the treatment of glaucoma.

Alkem Laboratories Ltd.

Valsartan

FDA approved a generic version of Diovan by Novartis for the treatment of high blood pressure and heart failure.

Amneal Pharmaceuticals Co.

Levomilnacipran extended-release capsules

FDA approved a generic version of Fetzima Extended-Release by Allergan for the treatment of Major Depressive Disorder.

Celgene

fedratinib

FDA granted priority review for the treatment of myelofibrosis.

Espero BioPharma 

Tecarfarin

FDA granted orphan drug designation for the prevention of systemic thromboembolism of cardiac origin in patients with end stage renal disease and atrial fibrillation.

Glenmark Pharmaceuticals Ltd. 

sevelamer hydrochloride tablets

FDA approved a generic version of Renagel by Sanofi for the control of serum phosphorus in patients with chronic kidney disease on dialysis.

Janssen Pharmaceuticals Inc.

Spravato

esketamine nasal spray

FDA approved Spravato in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression).

Micro Labs Limited, India

levofloxacin ophthalmic solution

FDA approved a generic version of Iquix by Vistakon Pharmaceuticals for the treatment of corneal ulcer caused by susceptible strains of specified bacteria.

Mitochon Pharmaceuticals 

MP-101

FDA granted orphan drug designation for the treatment of Huntington disease.

Novitium Pharma LLC 

pyridostigmine bromide syrup

FDA approved a generic version of Mestinon by Valeant Pharmaceuticals to improve muscle strength in patients with myasthenia gravis.

Perrigo UK FINCO Ltd. 

acyclovir cream, 5%

FDA approved a generic version of Zovirax by GlaxoSmithKline for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older.

Pfizer

Trazimera

trastuzumab-qyyp

FDA approved a biosimilar of Herceptin by Genentech for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Roche

Tecentriq plus chemotherapy

atezolizumab plus Abraxane (paclitaxel protein-bound particles for injectable suspension [albumin-bound]; nab-paclitaxel)

FDA approved the therapeutic for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumours express PD-L1.

Sanofi

Dupixent

dupilumab

FDA approved Dupixent for the treatment of moderate-to-severe atopic dermatitis in adolescents.

Taro Pharmaceuticals Industries Ltd.

deferiprone tablets

FDA approved a generic version of Ferriprox by ApoPharma for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.


 

ANIMAL

Company Trade Name Generic Name Action
Provetica AH LLC Doxidyl deracoxib

FDA approved Doxidyl for the control of pain and inflammation associated with osteoarthritis in dogs, for the control of postoperative pain and inflammation associated with orthopedic surgery in dogs, and for the control of postoperative pain and inflammation associated with dental surgery in dogs.


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