NEWS 31 OCT 2018

NEWS FROM USA

NDA Approvals        

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
19 Oct 2018	Meloxicam Disintegrating Tablets	Tersera	Qmiiz ODT	Label
28 Oct 2018	Estradiol;Progesterone Capsule	Therapeuticsmd	Bijuva	Label

 

 

ANDA Approvals 

 

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
26 Oct 2018	Teriflunomide Tablets	Aurobindo	Aubagio (Sanofi )	Three
26 Oct 2018	Felodipine ER Tablets	Yiling Pharm	N/A	Ten
26 Oct 2018	Progesterone Capsule	Eugia	Prometrium (Virtus)	Six
26 Oct 2018	Clobetasol Propionate Lotion	Hi-Tech	Clobex (Galderma )	Four
26 Oct 2018	Albuterol Sulfate Tablets	Novitium	N/A	Four
26 Oct 2018	Quetiapine Fumarate ER Tablets	Amneal	Seroquel XR (Astrazeneca)	Ten
26 Oct 2018	Methocarbamol Solution	Gland Pharma	Robaxin (West-Ward)	Nine
26 Oct 2018	Liothyronine Sodium Tablets	Teva	Cytomel (King)	Four
29 Oct 2018	Midodrine Hydrochloride Tablets	Par Pharm	N/A	Five
30 Oct 2018	Glycopyrrolate Tablets	Aurolife	N/A	Nine
30 Oct 2018	Fluocinolone Acetonide Topical Oil (Scalp Oil)	Glenmark	Derma-Smoothe/FS (Hill Dermaceuticals)	Ten

                                               

Tentative ANDA Approvals                       

Approval Date	Drug	Company
26 Oct 2018	Methylergonovine Maleate	Teva

 

NEW GENERICS LAUNCHES IN US

 

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Atomoxetine Capsule	DR Reddy	Strattera (Eli Lilly)	$ 304 Million	Link

 

USFDA Inspection

 

Dr Reddy's gets 8 observations from USFDA for Duvvada plant

                                               

Now, you can also follow us on twitter @pharmacaptions. If you have any query/suggestion then please write us at pharmacaption@gmail.com

                                                                                                                     

 

 

 

                                                                

NEWS 29 OCT 2018

|

NEWS FROM USA

ANDA Approvals 

 

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
25 Oct 2018	Fluocinolone Acetonide Topical Oil	Glenmark	Derma-Smoothe/Fs (Hill Dermac)	Nine
26 Oct 2018	Clobetasol Propionate Lotion	Akorn	Clobex (Galderma )	Four
29 Oct 2018	Metoprolol Succinate ER Tablets	Cipla	Toprol XL (Aralez Pharma)	Seven

 

Tentative ANDA Approvals                       

Approval Date	Drug	Company
24 Oct 2018	Temsirolimus	Gland

 

 

USFDA Inspection

 

USFDA completed inspection in Granules pharmaceuticals

                                               

Now, you can also follow us on twitter @pharmacaptions. If you have any query/suggestion then please write us at pharmacaption@gmail.com

                                                                                                                     

 

 

 

                                                                

NEWS 26 OCT 2018

NEWS FROM USA

NDA Approvals        

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
24 Oct 2018	Baloxavir Marboxil Tablets	Shionogi	Xofluza	Label

 

ANDA Approvals 

 

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
24 Oct 2018	Dalfampridine ER Tablets	West-Ward	Ampyra (Acorda)	Four
24 Oct 2018	Acetaminophen; Hydrocodone Bitartrate Tablets	Alvogen Pine	None	Fourteen

 

NEW GENERICS LAUNCHES IN US

 

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Arsenic Trioxide Injection	Fresenius Kabi	Trisenox (Cephalone)	N/A	Link

                                               

Now, you can also follow us on twitter @pharmacaptions. If you have any query/suggestion then please write us at pharmacaption@gmail.com

                                                                                                                     

 

 

 

                                                                

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

 

Now, you can also follow us on twitter @pharmacaptions. If you have any query/suggestion then please write us at pharmacaption@gmail.com