NEWS 26 FEB 2019

NEWS FROM THE USA 

505(b)2S in Pipeline

Diroximel Fumarate (Alkermes And Biogen): Alkermes And Biogen announce USFDA acceptance of Diroximel Fumarate NDA for Multiple Sclerosis.

NEW GENERICS LAUNCHES IN THE US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Minocycline Hydrochloride ER Tablets	Lupin	Solodyn (Medicis Pharma)	$76.8 Millions	Link

 

ANDA Approvals                                                  

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
21 Feb 2019	Calcitriol Capsules	Sun Pharm	Rocaltrol (Validus)	Five
21 Feb 2019	Aripiprazole Tablets	Alkem Labs	Abilify (Otsuka)	More Than 10
21 Feb 2019	Exemestane Tablets	Breckenridge	Aromasin (Pharmacia And Upjohn)	Seven
22 Feb 2019	Niacin ER Tablets	Mylan Pharms	Niaspan (Abbvie)	Seven
22 Feb 2019	Meclizine Hydrochloride Tablets	Indicus	N/A	Six
22 Feb 2019	Gemcitabine Hydrochloride Injection	Shilpa Medicare	Gemzar (Lilly)	More Than 10
22 Feb 2019	Methylprednisolone Tablets	Lupin	Medrol (Pharmacia And Upjohn)	Seven
22 Feb 2019	Busulfan Injection	Accord Hlthcare	Busulfex (Otsuka)	Nine
22 Feb 2019	Olmesartan Medoxomil Tablets	Sunshine	Benicar (Daiichi)	More Than 10
22 Feb 2019	Benzonatate Capsule	Ascent Pharms	Tessalon (Pfizer)	More Than 10
22 Feb 2019	Clofarabine Solution	Accord	Clolar (Genzyme)	Eight

 

Tentative ANDA Approvals 

Approval Date	Drug	Company
21 Feb 2019	Dimethyl Fumarate	Hetero Labs

 

 

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New product specific guidances published by FDA on Feb 22, 2019

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)

 

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

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

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

NEWS 17 FEB 2019

NEWS FROM USA

NEW GENERICS LAUNCHES IN THE US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Abiraterone* tablets	Hikma	Zytiga (Janssen)	$1.8 Billions	Link
Clobazam oral suspension	Lupin	Onfi (Lundbeck)	$253 Millions	Link
Tolterodine tartarate ER capsules	Camber	Detrol LA (Pharmacia)	N/A	Link

*Hikma’s shared exclusivity for Abiraterone along with other first filers shall end on 29 Apr. 2019 (based on PC exclusivity listed in Amneal’s ANDA)

 

NEW PC (PATENT CHALLENGE) EXCLUSIVITY LISTING IN THE ORANGE BOOK

DRUG	COMPANY	Corresponding RLD	PC exclusivity expiration date	Other TA holders
Abiraterone tablets	Amneal	Zytiga (Janssen)	29 Apr. 2019	Glenmark & Wockhardt
Dalfampridine ER tablets	Accord	Ampyra (Acorda)	9 Mar. 2019	Sun, Mylan, Teva & Micro

 

NEW CGT (COMPETITIVE GENERIC THERAPY) EXCLUSIVITY LISTING IN THE ORANGE BOOK

DRUG	COMPANY	Corresponding RLD	CGT exclusivity expiration date
Hydrocortisone Valerate ointment	Glenmark	Westcort (Sun)	16 July 2019

 

ANDA Approvals                                                  

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
13 Feb 2019	Fluocinolone acetonide 0.01% topical solution	Encube	Synalar (Medimetriks)	Five
13 Feb 2019	Moxifloxacin eye drops	Alembic	Vigamox (Novartis)	Five
12 Feb 2019	Mycophenolate Mofetil suspension	Vistapharm	Cellcept (Roche)	One (Alkem)
14 Feb 2019	Diphenhydramine and Ibuprofen capsules	Aurobindo	Advil PM (Pfizer)	Two (Strides, Bionpharma)

           

 

Other news from the USA

USFDA issued draft guidance on competitive generic therapy (Link for the guidance copy)

USFDA Inspections

Dr. Reddy’s Laboratories (Duvvada formulation facility): USFDA lifted warning letter on Dr. Reddy’s one of the formulation manufacturing facilities.

NEWS FROM EUROPE

Pegfilgrastim biosimilar (Europe): Mundi pharma launches Pegfilgrastim biosimilar in European countries (Germany, the Netherlands and Ireland)

 

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