NEWS 19 June 2019

NEWS FROM USA

505(b)2 APPROVAL

 

Approval Date	Product Name	NDA Sponsor	Brand Name	Prescribing information
13 June 2019	Budesonide ER capsules (6 mg and 9 mg)	Sun Pharma	Ortikos	Link

 

 

NEW EXCLUSIVITY LISTINGS IN THE ORANGE BOOK

 

New PC (Patent Challenge) exclusivity listing in the orange book

Drug	Applicant	Corresponding RLD	PC exclusivity expiration date	Other TA holders
Erlotinib hydrochloride tablets	Mylan	Tarceva (OSI)	5 Nov. 2019	Natco

 

New CGT (competitive generic therapy) exclusivity listing in the orange book

Drug	Applicant	Corresponding RLD	CGT exclusivity expiration date
Sildenafil powder for oral suspension	Novitium	Revatio (Pfizer)	27 Nov. 2019

 

NEW PARAGRAPH IV FILING

DRUG	Dosage form	Corresponding RLD	Date of Submission	Type of Submission (Based on Date)
Halobetasol Propionate	Lotion 0.01%	Bryhali (Bausch)	20 Mar. 2019	Open First to File#
Gabapentin Enacarbil	Extended-release Tablets	Horizant	29 April 2019	Open First to File

#NDA of Bryhali was approved by USFDA on 6 Nov. 2018. First Para IV filing was done within 4 and half months of FDA approval.

Full list of Paragraph IV Patent certifications: Link

505(b)2 IN PIPELINE

Lamotrigine oral liquid (Eton/Aucta pharma):  Eton Pharmaceuticals Announces Licensing of Lamotrigine New Drug Application.

-      Eton Pharmaceuticals, Inc has entered into an agreement with Aucta Pharmaceuticals, Inc to acquire U.S. marketing rights for ET-105.

-      Aucta pharma submitted the product’s New Drug Application (NDA) to the FDA in May 2019.

-      Lamotrigine is currently only approved in tablet formulations, and Eton believes ET-105 will fulfill a significant unmet need for pediatric patients requiring precision dosing.

-      Full Press Release: Link

 

ANDA APPROVALS

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
12 June 2019	Paliperidone ER tablets	Inventia	Invega (Janssen)	Three
12 June 2019	Loratidine chewable tablets	Perrigo	Children’s Claritin (Bayer)	One (Sun)
12 June 2019	Vancomycin injection	Hainan polypharma	Vancocin (Baxter)	Ten
13 June 2019	Dorzolamide, Timolol ophthalmic drops	FDC	Cosopt (Oak pharma)	Seven
14 June 2019	Diltiazem ER capsules	Novast	Cardizem CD (Bausch)	Seven
14 June 2019	Omega-3 acid ethyl ester	Zydus	Lovaza (Smithkline Beecham)	Six
17 June 2019	Potassium chloride ER tablets	PII	K-tab (Abbvie)	One (Virtuvias)
18 June 2019	Diclofenac sodium 37.5 mg/ml	Mylan	Dyloject (javelin)	None

 

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