NEWS 20 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	Alvogen	Suboxone (Indivior)	N/A	Link
Buprenorphine hydrochloride/naloxone hydrochloride Sublingual Film	Sandoz	Suboxone (Indivior)	$2 Billions	Link

 

NDA Approvals                    

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
15 Feb 2019	Vancomycin Injection	Xellia Pharms	Vancomycin	Link

 

ANDA Approvals                                                  

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
15 Feb 2019	Clobetasol Propionate Foam	Glenmark	Olux (Mylan)	Three
15 Feb 2019	Oxaliplatin Injection	Sun Pharma	Oxaliplatin (Teva)	More Than 10
15 Feb 2019	Prochlorperazine Edisylate Injection	Nexus	N/A	Four
15 Feb 2019	Risedronate Sodium Tablets	Hangzhou	Actonel (Apil)	Six
15 Feb 2019	Clotrimazole Topical Solution	Novitium	N/A	Two (Taro, Teva)
19 Feb 2019	Acetazolamide ER Capsules	Alembic	Diamox (Teva Branded)	Six
20 Feb 2019	Ethosuximide Softgel Capsules	Strides Pharma	Zarontin (Pfizer)	Three

 

Tentative ANDA Approvals 

Approval Date	Drug	Company
15 Feb 2019	Bendamustine Hydrochloride	Pharmascience
15 Feb 2019	Everolimus	Teva Pharma

 

505(b)2s in pipeline

Synthetic adrenocorticotropic hormone, or ACTH (Assertio): Assertio announced the FDA acceptance of long-acting injectable formulation of Cosyntropin.

Teriparatide (Pfenex): Pfenex announced the FDA acceptance of PF708, 505(b)(2) NDA against Forteo. PDUFA date: October 7, 2019.

 

NEWS FROM THE EUROPE

Bevacizumab Biosimilar (Pfizer): Pfizer Receives European Approval for Zirabev (Bevacizumab), a Biosimilar To Avastin

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