NEWS 24 FEB 2019

NEWS FROM THE USA 

NEW GENERICS LAUNCHES IN THE US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Buprenorphine hydrochloride/naloxone hydrochloride Sublingual Film	Mylan	Suboxone (Indivior)	$1.87 Billions	Link

 

ANDA Approvals                                                  

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
19 Feb 2019	Telmisartan Tablets	Hisun Pharm Hangzhou	Micardis (Boehringer)	More Than 10
19 Feb 2019	Levothyroxine Sodium Tablets	Amneal	Levo-T (Cediprof)	Four
19 Feb 2019	Bupivacaine Hydrochloride Injection	Novocol	Marcaine Hydrochloride (Hospira)	More Than 10
19 Feb 2019	Colchicine Tablets	Zydus	Colcrys (Takeda)	Two (Alkem, Amneal)
20 Feb 2019	Cisatracurium Besylate Injection	Somerset	Nimbex (Abbvie)	Nine
20 Feb 2019	Phytonadione Tablet	Zydus	Mephyton (Valeant)	One (Amneal)

 

Tentative ANDA Approvals 

Approval Date	Drug	Company
20 Feb 2019	Esomeprazole Magnesium;Naproxen	Mylan
20 Feb 2019	Dimethyl Fumarate	Torrent

 

OTHER NEWS FROM THE US

·      FDA published 22 new product specific guidances for generic drug development. FDA also revised guidances for 52 products (Link for the guidance)

 

·      Bendamustine (Bendeka): FDA grants Orphan drug exclusivity to Bendeka till 7 Dec. 2022; no bendamustine product (including generic versions of TREANDA^®) may launch in the United States until December 7, 2022 unless it is clinically superior to BENDEKA. (Source: Form 8-k of Eagle pharma dated 21 Feb. 2019)

 

·     Beximco Pharma to Acquire Eight ANDAs from Sandoz Inc. (Link)

 

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