NEWS 07 JAN 2019

NEWS FROM THE USA

505 (b) 2s in pipeline

Naloxone Pre-Filled Single Dose Syringe (Adamis Pharma): Adamis Pharma announced the submission of a NDA to USFDA for naloxone pre-filled single dose syringe (PFS) for the treatment of an opioid overdose.

Monomethyl Fumarate Prodrug (Banner Pharma): Banner pharma Banner Receives FDA Tentative Approval for BAFIERTAM for the Treatment of Relapsing Forms of Multiple Sclerosis.

NEW GENERICS LAUNCHES IN THE US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Epinephrine Inhalation Aerosol Bronchodilator Suspension	Amphastar Pharmaceutical	Primatene (Mist)	$ 0.7 Billion	Link

 

ANDA Approvals                                                  

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
03 Jan 2019	Pramipexole Dihydrochloride ER Tablets	Alembic	Mirapex Er (Boehringer)	Six
02 Jan 2019	Gentamicin Sulfate Ointment	Teligent Pharma	N/A	Four Plan To Launch In February Of 2019
03 Jan 2019	Lurasidone Hydrochloride	Amneal	Latuda (Sunovion)	Four
03 Jan 2019	Lurasidone Hydrochloride	Invagen	Latuda (Sunovion)	Four
03 Jan 2019	Lurasidone Hydrochloride	Lupin	Latuda (Sunovion)	Four
03 Jan 2019	LURASIDONE HYDROCHLORIDE	Accord	Latuda (Sunovion)	Four
03 Jan 2019	LURASIDONE HYDROCHLORIDE	Torrent	Latuda (Sunovion)	Four

 

 

Generic Patent Litigation:

Teva and Amgen Resolve Ongoing Dispute Over Teva’s Generic Cinacalet HCl Product

Ironwood and Allergan Announce Settlement with Mylan Resolving LINZESS (linaclotide) Patent Litigation

Tentative ANDA Approvals 

Approval Date	Drug	Company
02 Jan 2019	Dalfampridine	Micro Labs

 

 

 

 

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