Showing posts with label new us fda approvals. Show all posts
Showing posts with label new us fda approvals. Show all posts

VIMPAT(lacosamide) mono therapy approved by US FDA for treatment in Epilepsis

sNDA (supplemental new drug application) of VIMPAT (lacosamide)an Anti-epileptic drug approved by US FDA as mono therapy in partial onset seizures .
Epilepsy is a chronic neurological disorder,which can occur across all ages,races and genders where in two or more unproved seizures occur at least one day ( 24 hours) apart .
VIMPAT(lacosamide) is available in various forms like tablets,oral solutions or injections .
Mono therapy is the treatment of a disease with a single drug which is opposite to combination therapy(multiple drugs) ,VIMPAT(lacosamide) is already approved in US as adjunctive treatment (with other drugs) for partial onset seizures in 17 years and older.
The adverse reactions seen in mono therapy study were similar to those in combination with others except insomnia which is greater than 2% .
VIMAT(lacosamide) Safety Information 
-Suicidal behavior : Including VIMPAT, all Anti -Epileptic drugs (AED's) increase the risk of suicidal thoughts and change in formation of ideas or concepts.Patients under VIMPAT  therapy shall be monitored for worsening of depression ,suicidal thoughts.
-Dizziness and Ataxia: VIMPAT may cause dizziness and ataxia and hence patients taking VIMPAT should be discouraged to perform /operate complex machinenary.

Promacta (eltrombopag) sNDA of GlaxoSmithKline gets US FDA approval for treatment in Severe aplastic anaemia


Promacta(eltrombopag)  once daily use drug for use in patients with Sever Aplastic Anaemia(SAA)  who do not respond sufficiently to Imuunosuprresvie therpay(IST) is developed by GSK and gets sNDA approval from United States Food and Drug Administration(US FDA) .Earlier Promacta  gained breakthrough therapy desigantion status in January '14.
Sever aplastic Anaemia is a serious blood disorder  where the bone marrow fails to generate enough new Red and White Blood cells and Platelets. 300 to600 new SAA cases are reported every year in United States of America (USA)
Eltrombopag is a small molecule agonist of the c-mpl (TpoR) receptor, which is the physiological target of the hormone thrombopoietin

Zorvolex(dicofenac) for management of Osteoarthritis(joint disorder) from Iroko Pharma gets US FDA approval

Zorvolex(dicofenac) for management of Osteoarthritis(joint disorder) from Iroko Pharma gets US FDA approval.Zorvolex(diclofenac) is developed with proprietary SoluMatrix FINE PARTICLE TECHNOLOGY  in which diclofenac is in submicron particles form that are approximately 20 times smaller than original size.This reduction in particle size results in increased surface area which leads to faster dissolution , prompt effect.
According to Iroko Pharma, Zorvolex was developed keeping in line with recommendations from US FDA and others that NSAIDs be used in lowest effective dose for short possible duration with individual patient treatment goal.