NEWS 03 APR 2019

NEWS FROM USA

505(b)2s in pipeline

Rizaport (Intelgex): Intelgex received CRL from the USFDA for its 505(b)2 NDA for Rizaport for the treatment of Acute migraines.

Gimoti (Evoke Pharma): Evoke Pharma received CRL from the USFDA for its 505(b)2 NDA for Gimoti for the relief of symptoms associated with acute and recurrent diabetic gastroparesis.

 

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Potassium Chloride Extended-Release Tablets	Strides Pharma	Potassium Chloride Extended-Release Tablets (Merck)	$240 Million	Link
Tadalafil Tablets	Lupin	Cialis (Eli Lilly)	$1780 Million	Link

 

NDA Approvals                    

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
29 Mar 2019	Cladribine	Emd Serono	Mavenclad	Link
29 Mar 2019	Acyclovir Ointment	Fera Pharma	Avaclyr	Link

 

ANDA Approvals

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
01 Apr 2019	Docetaxel Injection	Mylan	Docetaxel (Accord)	Three
01 Apr 2019	Levocetirizine Dihydrochloride Solution	Hetero	Xyzal (Sanofi)	Four
29 Mar 2019	Potassium Chloride Er Tablets	Pii	N/A	Four
29 Mar 2019	Rasagiline Mesylate Tablets	Micro Labs	Azilect (Teva)	Five
29 Mar 2019	Azelastine Solution Hydrochloride	Somerset	N/A	Five
29 Mar 2019	Potassium Chloride Solution	Pharm Assoc	Potassium Chloride (Genus)	Three

 

Tentative ANDA Approvals

Approval Date	Drug	Company
01 Apr 2019	Mirabegron ER Tablets	Zydus
01 Apr 2019	Pantoprazole Sodium	Hangzhou Zhongmei
02 Apr 2019	Betamethasone Dipropionate	Perrigo

 

USFDA Inspection

Strides Pharma (Singapore Facility): Receipt of Establishment Inspection Report (EIR) from US FDA for Singapore facility

Lupin (Pithampur Unit-3): Lupin’s Pithampur Unit-3 (Indore) receives EIR from U.S. FDA

Lupin (Bioresearch Centre): Lupin Bioresearch Centre completes fifth successful U.S. FDA inspection

 

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