NEWS 04 FEB 2019

NEWS FROM USA

NDA Approvals                    

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
30 Jan 2019	Amphetamine Sulfate ODT	Arbor Pharms	Evekeo ODT	Link
30 Jan 2019	Colchicine Solution	Romeg Therapeutics	Gloperba	Link

 

ANDA Approvals                                                  

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
28 Jan 2019	Nystatin Ointment	Torrent	N/A	Six
29 Jan 2019	Aripiprazole Solution	Aurobindo	N/A	Three
29 Jan 2019	Phenylephrine Hydrochloride IV Solution (10mg/Ml)	Fresenius	Vazculep (Avadel)	Five
30 Jan 2019	Phenylephrine Hydrochloride IV Solution (50mg/5ml & 100mg/10ml)	Fresenius	Vazculep (Avadel)	Four
30 Jan 2019	Desonide Ointment	Encube	Desonide (Perrigo)	Five
30 Jan 2019	Fluoxetine Hydrochloride Tablets	Appco	N/A	Five
30 Jan 2019	Clobazam Tablets	Micro Labs	Onfi (Lundbeck)	Ten
31 Jan 2019	Phenylephrine Hydrochloride IV Solution	Sandoz	Vazculep (Avadel)	Five
31 Jan 2019	Ranitidine Hydrochloride Tablets	Vkt Pharma	N/A	Eleven
31 Jan 2019	Tacrolimus Ointment	Accord	Protopic (Leo)	One (Fougera)

 

Tentative NDA Approvals                                       

Approval Date	Drug	Company
29 Jan 2019	Bendamustine	Hospira
30 Jan 2019	Budesonide	Sun Pharma

 

 

Tentative ANDA Approvals 

Approval Date	Drug	Company
29 Jan 2019	Alogliptin	Msn Labs
30 Jan 2019	Ceftaroline Fosamil	Apotex Inc
03 Feb 2019	Tenofovir/Lamivudine/Dolutegravir Fixed dose combination	Laurus Lab

                         

 

 

 

 

 

USFDA Inspections 

Laurus Labs received an EIR from USFDA for its Unit 6 at Andhra Pradesh Facility

 

Other News from the USA

Ibrutinib Tablets (Natco Pharma): Natco pharma submitted ANDA Application containing a paragraph IV certification with the USFDA for generic version of Ibrutinib Tablets of 140mg, 280mg, 420mg and 560mg 

 

If you have any query/suggestion then please write us at pharmacaption@gmail.com