NEWS 26 MAR 2019

NEWS FROM USA

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Treprostinil Injection	Sandoz*	Remodulin	$599 Million (As per the last annual report)	Link
Deferasirox Tablets	Teva#	Exjade	$134 Million	Link

*As per the press release, Sandoz has received 180 days exclusivity for this product.

#As per the final approval letter, Teva is eligible for 180 days exclusivity. However, the only exclusivity bearing patent is set to expire on 5 Apr. 2019 and in absence of any paediatric extension, there is a possibility that at least one subsequent filer may launch its product on or after 6 Apr. 2019.

 

ANDA Approvals

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
25 Mar 2019	Hydroxyprogesterone Caproate Injection	Slaybsck Pharma	Makena Preservative Free (Amag Pharma)	One (Luitpold)
25 Mar 2019	Sildenafil Tablets	Lupin	Viagra Tablets (Pfizer)	Seven
22 Mar 2019	Drospirenone; Ethinyl Estradiol Tablets	Hetero	Yaz (Bayer)	Ten
22 Mar 2019	Bimatoprost Solution	Gland Pharma	N/A	Four
22 Mar 2019	Roflumilast Tablets	Micro Labs	Daliresp (Astrazeneca Pharms)	Three
22 Mar 2019	Aliskiren Hemifumarate Tablets	Anchen Pharms	Tekturna (Noden)	None
21 Mar 2019	Lamivudine Tablets	Annora	Epivir-Hbv (GSK)	Three
20 Mar 2019	Glycopyrrolate Injection	Caplin	N/A	Nine
20 Mar 2019	Methylergonovine Maleate Tablets	Teva Pharms	N/A	Three

 

Tentative NDA Approvals 

Approval Date	Drug	Company
25 Mar 2019	Dolutegravir;Lamivudine;Tenofovir Disoproxil Fumarate	Macleods

 

Tentative ANDA Approvals 

Approval Date	Drug	Company
22 Mar 2019	Dimethyl Fumarate	Msn Lab
25 Mar 2019	Dimethyl Fumarate	Sawai Usa
25 Mar 2019	Lurasidone Hydrochloride	Piramal Healthcare
25 Mar 2019	Armodafinil	Apotex

 

USFDA Inspections

Sun Pharma (Baska Plant): Sun pharma gets FDA Observation for Baska Plant.

 

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