NEWS 12 MAY 2019

NEWS FROM USA

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Erlotinib Tablets*	Teva Pharma	Tarceva (OSI)	$212 Million	Link
	Mylan			Link
Mesalamine DR capsules	Teva	Delzicol (Allergan)	$130 Million	Link
Clobazam tablets	Lupin	Onfi (Lunbeck)	$479 Million	Link

*Other Erlotinib generic filers including Natco and others may launch their products in Nov. 2019.

 

NDA APPROVALS

 

Approval Date	Product Name	NDA Sponsor	Brand Name	Prescribing information
06 May 2019	Amifampridine Tablets	Jacobus Pharma	Ruzurgi	Link

 

ANDA APPROVALS

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
03 May 2019	Fentanyl Citrate Injection	Fresenius Kabi	Sublimaze Preservative Free (Akorn)	Three
06 May 2019	Arsenic Trioxide Injection	STI Pharma	Trisenox (Cephalon)	Five
06 May 2019	Colesevelam Hydrochloride Oral Suspension	Alkem	Welchol (Daiichi)	One (Glenmark)
06 May 2019	Potassium Chloride Oral Suspension	Belcher Pharms	Potassium Chloride (Pharma Res)	Three
08 May 2019	Penicillamine Capsules	Amerigen Pharma	Cuprimine (Bausch Heath’s)	None*

*Penicillamine was mentioned in FDA’s latest off-patent off-exclusivity products without an approved generic list. 

 

TENTATIVE ANDA APPROVALS

Approval Date	Drug	Company
07 May 2019	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride ER Tablets	Unichem Lab
09 May 2019	Lacosamide	Hetero labs

                       

 

NEW USFDA GUIDANCE:

FDA published final guidance on determining whether to submit an ANDA or a 505(b)(2) application (Link)

 

FDA published Final guidance on considerations in demonstrating interchangeability with a reference product (Link)

 

 

OTHER NEWS FROM US:

Innovus Pharma Announces a Second Partnered United States OTC ANDA for Minoxidil 5% Foam for Men and Women (Link)

 

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