NEWS 04 DEC 2018

NEWS FROM USA

ANDA Approvals 

 

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
03 Dec 2018	Silodosin Capsule	Lupin	Rapaflo (Allergan)	Five (All of them approved on the same days as product patent expired on 1 Dec. 2018)
03 Dec 2018	Silodosin Capsule	Amneal
03 Dec 2018	Silodosin Capsule	Msn Labs
03 Dec 2018	Silodosin Capsule	Ajanta
03 Dec 2018	Silodosin Capsule	Macleods
30 Nov 2018	Bismuth Subsalicylate; Metronidazole; Tetracycline Hydrochloride Tablets & Capsules	Ailex	Pylera (Allergan)	None
30 Nov 2018	Glycopyrrolate Tablets	Orit Labs	Robinul (Casper)	Nine
30 Nov 2018	Lamotrigine ER Tablets	Amneal Pharms	Lamictal XR  (GSK)	Six
30 Nov 2018	Etodolac Tablets	Edenbridge	Etodolac (Taro)	Five
30 Nov 2018	Methylphenidate Hydrochloride ER Tablets	Alvogen	Concerta (Janssen)	Five

 

NEW GENERICS LAUNCHES IN US

 

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Silodosin Capsules	Lupin	Rapaflo (Allergan)	$198.5 Million	Link
Lansoprazole Delayed-Release (DR) Orally Disintegrating Tablets (ODT)	Mylan	Prevacid (Takeda)	$168 Million	Link

                            

Tentative ANDA Approvals

 

Approval Date	Drug	Company
28 Nov 2018	Amphetamine Aspartate;Amphetamine Sulfate;Dextroamphetamine Saccharate;Dextroamphetamine Sulfate	Amerigen
28 Nov 2018	Linagliptin	Zydus
29 Nov 2018	Oxcarbazepine	Twi Pharms
29 Nov 2018	Mesalamine	Zydus

                                               

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