USFDA

Shire plc, a leading global biotechnology company, announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for two investigational products for rare diseases: SHP621 (budesonide oral suspension, or BOS) for eosinophilic esophagitis (EoE), and SHP625 (maralixibat) for progressive familial intrahepatic cholestasis type 2 (PFIC2).

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ProMetic Life Sciences Inc. reported  that the U.S. Food and Drug Administration (FDA) has granted a Fast Track designation to ProMetic for its plasminogen drug candidate, currently in a phase 2/3 clinical trial in patients suffering from congenital Plasminogen deficiency.

 Remedy Pharmaceuticals, a privately-held pharmaceutical company focused on bringing life-saving hospital-based treatment to people affected by central nervous system (CNS) related edema, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational drug, CIRARA, for the treatment of Large Hemispheric Infarctions (LHI).

Allergan plc announced the approval of BYVALSON™ (nebivolol and valsartan) 5 mg/ 80 mg tablets, by the U.S. Food and Drug Administration (FDA) for the treatment of hypertension to lower blood pressure. BYVALSON is the first and only fixed-dose combination (FDC) of a beta blocker (BB) and angiotensin II receptor blocker (ARB) available in the U.S.

Adamis Pharmaceuticals Corporation announced that after the close of the stock markets on June 3, 2016 it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) Epinephrine Injection USP 1:1000 0.3mg Pre-filled Single Dose Syringe (PFS) product.  PFS is for the emergency treatment of acute anaphylaxis, which is a severe allergic reaction.   A CRL is issued by the FDA's Center for Drug Evaluation and Research when it has

Vertex Pharmaceuticals Incorporated, a global biotechnology company, announced that the US Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the use of Orkambi (lumacaftor/ivacaftor) in people with cystic fibrosis (CF) ages 6 to 11 who have two copies of the F508del mutation. The FDA granted Vertex's request for Priority Review of this sNDA, and a target review date of September 30, 2016 was set under the Prescription Drug User Fee Act (PDUFA).

Strides Shasun Limited has received the first to file tentative approval from the United States Food & Drug Administration (USFDA) for Roflumilast tablets, 500 mcg. The product received approval in 15 months under the new the Generic Drug User Fee Amendments of 2012 (GDUFA) goal date regime. The product can be launched earliest by January 2020.

BioVentrix Inc., an emerging medical device company for less invasive treatment of heart failure (HF), announced that it has received a US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial, named ALIVE (American Less Invasive Ventricular Enhancement). The trial is designed to demonstrate the safety and effectiveness of the Revivent TC TransCatheter; a hybrid closed-chest transcatheter procedure to treat patients suffering from ischemic cardiomyopathy by reshaping and restoring the left ventricle (LV).  This is accomplished by implanting micro-anchoring pairs in the LV to exclude scarred myocardium from the healthy tissue.

CordenPharma International would like to notify customers about a warning letter received from the USFDA on May 24, 2016 in its CordenPharma Latina facility in Sermoneta, Italy. This action follows an earlier inspection of the site by the agency in May 2015.

One of India’s largest sterile Injectables company, Claris Lifesciences Limited (Claris/Company), announced today that it has received the Establishment Inspection Report (EIR) for its manufacturing facility located near Ahmedabad, wherein the US FDA has concluded that the inspection stands closed and the facility was found to be acceptable.