Saxenda (Liraglutide) of Novo Nordisk received 14-1 positive vote for approval from EMDAC of US FDA.

Saxenda (Liraglutide) of Novo Nordisk received 14-1 positive vote for approval from EMDAC ( Endocrinologic an Metabolic Drugs Advisory  Committee) of US FDA.
The panel members were asked to discuss whether Novo Nordisk has provided enough data to establish the safety and efficacy profile of Saxenda(Liraglutide)  for chronic weight management based on the NDA data submitted.
Overall benefit-risk assessment of Saxenda(Liraglutide) got 14-1 votes from the panel members for weight management in patients with BMI 30kg/m2 or greater.
       NDA for Saxenda(Liraglutide) was submitted on october 2013 with US FDA. The data submitted for NDA included phase 3 SCALET  clinical trial in which 5000 people with obesity were involved.

Aripiprazole Lauroxil,a Novel Drug of Alkemers has been submitted for NDA with US FDA

Aripiprazole Lauroxil,an Alkermes novel Drug  has been submitted for NDA (New Drug Application) approval from US FDA for use in treatment of Schizophrenia.Aripiprazole Lauroxil is an injectablee drug with one-month & two -month  formulations as an anti-psychotic for treatment of Schizophrenia.Aripiprazole lauroxil gets converted to Aripiprazole once administered in to the body,which is a long acting drug based on a unique , Akemers Propietary LinkeRX technology .

                        The positive results from pivotal phase 3 clinical study assessing the efficacy and safety studies in which this novel drug showed significant improvement of schizophrenia compared to placebo.

Chemistry of Aripiprazole Lauroxil

    Molecular Formula : C36H51Cl2N3O4
    Molecular Weight :660.71
    IUPAC name:[7-[4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy]-2-oxo-3,4-dihydroquinolin-1-yl]methyl dodecanoate

   Chemical Structure: