NEWS 24 OCT 2018

NEWS FROM USA

NDA Approvals        

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
19 Oct 2018	Levoleucovorin Injection	Spectrum Pharms	Khapzory	Link Earlier approved Levoleucovorin was calcium salt

 

ANDA Approvals 

 

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
17 Oct 2018	Lansoprazole Dr Capsule	Breckenridge Pharm	Prevacid (Takeda)	Thirteen
17 Oct 2018	Adapalene; Benzoyl Peroxide Topical Gel	Taro	Epiduo Forte (Galderma)	None
17 Oct 2018	Cefazolin Sodium Injection	Qilu Pharm	N/A	Five
17 Oct 2018	Ceftriaxone Sodium Injection	Qilu Pharm	N/A	Six
17 Oct 2018	Isoproterenol Hydrochloride Injection	Amneal Pharms	Isuprel (Hospira)	Three
18 Oct 2018	Capreomycin Sulfate Injection	Hisun Pharm	Capastat Sulfate (Akorn)	One (Mylan)
18 Oct 2018	Acetazolamide Er Capsule	Accord Hlthcare	Diamox (Teva)	Four
18 Oct 2018	Norepinephrine Bitartrate Injection	Sandoz	Levophed (Hospira)	Four
20 Oct 2018	Gabapentin Capsule	Strides	Neurontin (Pfizer)	Fifteen
22 Oct 2018	Clobazam Tablets	West-Ward Pharma	Onfi (Lundbeck) All the generics were approved on the same date as Onfi’s ODE expired on 21 Oct 2018	Eight
22 Oct 2018	Clobazam Suspension	Bionpharma		Four
22 Oct 2018	Clobazam Tablets	Bionpharma		Eight
22 Oct 2018	Clobazam Tablets	Breckenridge		Eight
22 Oct 2018	Clobazam Tablets	Taro Pharm		Eight
22 Oct 2018	Clobazam Tablets	Upsher-Smith		Eight
22 Oct 2018	Clobazam Suspension	West-Ward		Four
22 Oct 2018	Clobazam Tablets	Amneal		Eight
22 Oct 2018	Clobazam Tablets	Hetero Labs		Eight
22 Oct 2018	Clobazam Tablets	Piramal		Eight
22 Oct 2018	Clobazam Suspension	Amneal		Four
22 Oct 2018	Clobazam Suspension	Upsher		Four
22 Oct 2018	Clobazam Suspension	Mylan		Four
22 Oct 2018	Clobazam Tablets	Zydus		Eight
22 Oct 2018	Triamcinolone Acetonide Ointment	Lupin	Triamcinolone Acetonide Ointment (Mylan)	Eleven

*Highlighted products are the 1^st generics approval for the corresponding RLD

 

Tentative ANDA Approvals           

Approval Date	Drug	Company
12 Oct 2018	Alogliptin	Alembic
12 Oct 2018	Mifepristone	Teva
15 Oct 2018	Benzoyl Peroxide;Clindamycin Phosphate	Tolmar
16 Oct 2018	Fesoterodine Fumarate	Torrent
16 Oct 2018	Colchicine	Zydus
19 Oct 2018	Tadalafil	Amneal

 

NEW GENERICS LAUNCHES IN US

 

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Medroxyprogesterone Acetate Injectable Suspension	Mylan	Depo-Provera (Pfizer)	$ 181 Million	Link
Isoproterenol Hydrochloride	Amneal	Isuprel (HOSPIRA )	$158 Million	Link
Carmustine	Amneal	BiCNU (Emcure)	$84 Million	Link
Clobazam Tablets	Amneal	Onfi (Lundbeck)	$594 Million	Link
Clobazam Tablets	Camber (Hetero)	Onfi (Lundbeck)	$594 Million	Link
Clobazam Tablets	Bionpharma	Onfi (Lundbeck)	$594 Million	Link
Clobazam Suspension	Amneal	Onfi (Lundbeck)	$255 Million	Link
Clobazam Suspension	Bion pharma	Onfi (Lundbeck)	$255 Million	Link

 

USFDA INSPECTION

Lupin's Pithampur Unit-3 (Indore) Inspected by US FDA

 

NEWS FROM EUROPE

Positive CHMP opinions (EMA)

Drug	Sponsor	Indication
Mexiletine Hydrochloride	Lupin	Myotonia In Non-Dystrophic Myotonic Disorders
Ivacaftor	Vertex Pharma	Treat Patients With Cystic Fibrosis Aged 12 to <24 Months

 

Other News from Europe

·         Mylan and Biocon Announce Positive CHMP Opinion for Ogivri, Biosimilar Trastuzumab 

·         Mylan Launches Hulio (Biosimilar Adalimumab) in Markets Across Europe

 

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