NEWS 30 JAN 2019

NEWS FROM USA

New Paragraph IV filing

DRUG	Dosage form	Corresponding RLD	Date of Submission	Type of Submission (Based on Date)
Ibrutinib (140 And 560 Mg)	Tablets	Imbruvica	05 Nov 2018	Post NCE-1 Submission For New Dosage Form
Ibrutinib (280 And 420 Mg)	Tablets	Imbruvica	14 Dec 2018	Post NCE-1 Submission For New Dosage Form

 

NDA Approvals                    

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
28 Jan 2019	Sumatriptan Nasal Spray	Dr Reddys	Tosymra	Link

 

ANDA Approvals                                                  

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
25 Jan 2019	Diphenhydramine Hydrochloride; Naproxen Sodium Tablets	Actavis	Aleve Pm (Bayer)	One (Amneal)
25 Jan 2019	Eptifibatide Injection	Hainan Poly	Integrilin (Schering)	Eight
25 Jan 2019	Dicyclomine Hydrochloride Injection	Fresenius	Bentyl (Allergan)	Six
25 Jan 2019	Fluoxetine Hydrochloride Tablets	Dr Reddys	Fluoxetine Hydrochloride (Alvogen)	Five
25 Jan 2019	Tizanidine Hydrochloride Tablets	Alkem	Zanaflex (Covis)	Eleven
25 Jan 2019	Mesalamine DR Tablets	Sun Pharma	Lialda (Shire)	Three
28 Jan 2019	Calcium Chloride; Potassium Chloride; Sodium Chloride; Sodium Lactate Injection	Fresenius	Lactated Ringer's In Plastic Container (Baxter)	Two (B Braun, Icu Medical)
28 Jan 2019	Clindamycin Phosphate Topical Solution	Encube	Cleocin T (Pharmacia And Upjohn)	Ten
28 Jan 2019	Medroxyprogesterone Injectable	Cipla	Depo-Provera (Pfizer)	Five
28 Jan 2019	Desmopressin Acetate  Tablets	Abhai	Ddavp (Ferring)	Six
28 Jan 2019	Bupropion Hydrochloride ER Tablets	Graviti	Wellbutrin Xl (Valeant)	Seventeen
28 Jan 2019	Tazarotene Cream (1%)	Fougera	N/A	None

 

Tentative ANDA Approvals 

Approval Date	Drug	Company
22 Jan 2019	Topiramate	Glenmark
25 Jan 2019	Bendamustine Hydrochloride	Celerity Pharms
25 Jan 2019	Dextroamphetamine Saccharate	Sun Pharma
28 Jan 2019	Fosaprepitant Dimeglumine	MSN Labs
28 Jan 2019	Eslicarbazepine Acetate	Alkem Labs
29 Jan 2019	Pregabalin	Alkem Labs

 

 

 

 

 

 

 

 

 

 

USFDA Inspections 

Dishman gets EIR for its Bavla plant

 

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NEWS 28 JAN 2019

NEWS FROM USA

ANDA Approvals                                                  

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
23 Jan 2019	Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride Solution	Torrent	Rezira (Cypress)	Two (Mayne, Paddock)
23 Jan 2019	Ticagrelor Tablets	Amneal	Brilinta (Astrazeneca)	Two (Hisun Pharm, Watson )
23 Jan 2019	Ticagrelor Tablets	Hisun Pharm Hangzhou	Brilinta (Astrazeneca)	Two (Amneal, Watson )
23 Jan 2019	Clobetasol Propionate Ointment	Teligent	N/A	Ten
24 Jan 2019	Dorzolamide Hydrochloride Ophthalmic Drops	FDC Ltd	Trusopt (Merck)	Five
24 Jan 2019	Buprenorphine Hydrochloride; Naloxone Hydrochloride Sublingual	Alvogen Pine	Suboxone (Indivior)	Two (Dr Reddys, Mylan)
28 Jan 2019	Medroxyprogesterone Injectable	Cipla	Depo-Provera (Pfizer)	Five

 

Tentative ANDA Approvals 

Approval Date	Drug	Company
22 Jan 2019	Topiramate XR capsules	Glenmark

 

 

 

USFDA Inspections 

USDFA concludes audit at Indoco’s Goa Plant I

U.S. FDA completes inspection of Lupin’s Pithampur Unit-2 (Indore) facility

 

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

NEWS 24 JAN 2019

NEWS FROM USA

New Paragraph IV filing

DRUG	Dosage form	Corresponding RLD	Date of Submission	Type of Submission (Based on Date)
Ibrutinib (70 mg)	Capsules	Imbruvica	14 Dec. 2018	Post NCE-1 submission for new strength

 

NEW GENERICS LAUNCHES IN THE US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Propofol injectable emulsion	Dr. Reddy’s laboratories	Diprivan	$ 310 millions	Link

 

ANDA Approvals                                                  

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
18 Jan 2019	Imatinib Mesylate	Wockhardt	Gleevec (Novartis)	Seven
17 Jan 2019	Imatinib Mesylate	Shilpa Medicare	Gleevec (Novartis)	Seven
18 Jan 2019	Levothyroxine Tablets	Lupin	Synthroid (Abbvie)	Four
18 Jan 2019	Dexmedetomidine Hydrochloride Injection	Cipla	Precedex (Hospira)	Fourteen
18 Jan 2019	Lansoprazole DR Oral Capsule	Alkem Labs	Prevacid (Takeda)	Fourteen
18 Jan 2019	Cyclophosphamide Capsules	Cipla	Cyclophosphamide (West-Ward)	Two (Amerigen, Sti Pharma)
18 Jan 2019	Acyclovir Ointment	Cipla	Zovirax (Valeant)	Nine
22 Jan 2019	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate ER Capsules	Amerigen	Adderall Xr (Shire)	Four
22 Jan 2019	Potassium Chloride ER Tablets	Pii	Klor-Con (Upsher Smith)	Seven
22 Jan 2019	Dofetilide Capsules	Aurobindo	Tikosyn (Pfizer)	Five
22 Jan 2019	Tretinoin Cream	Taro	Retin-A (Valeant Pharms)	One (Perrigo)

           

Tentative ANDA Approvals 

Approval Date	Drug	Company
18 Jan 2019	Esomeprazole Magnesium	Zydus Pharms
18 Jan 2019	Carfilzomib	Apotex
18 Jan 2019	Carfilzomib	Qilu Pharma
18 Jan 2019	Dapagliflozin	Hetero Labs
22 Jan 2019	Abiraterone Acetate	Glenmark

 

 

 

 

 

 

 

 

 

 

 

NEWS RELATED TO GENERIC PATENT LITIGATION

Palonosetron (Helsinn v. Teva): US Supreme court rules in favour of Teva in Palonosetron on-sale bar case.

 

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