NEWS 12 JULY 2018

NEWS FROM USA

sNDA submission

DRUG	COMPANY	NEWS
Venetoclax (New indication – AML)	Abbvie	AbbVie Announces Submission of Supplemental New Drug Application to US FDA for Venetoclax in Newly Diagnosed Acute Myeloid Leukemia Patients Ineligible for Intensive Chemotherapy

 

NDA Approvals

DRUG	COMPANY	Comment
Atropine Injection   ( 2 mg/0.7 mL, Single-Dose Autoinjector)   Approval date: 09 July 2018	RAFA LAB	Prescribing information

 

ANDA Approvals

DRUG	COMPANY	NEWS
Nitrofurantoin	Lupin	Lupin receives FDA approval for generic Nitrofurantoin Capsules USP (Macrocrystals), 50 mg and 100 mg
Zolmitriptan	Zydus	Zydus receives final approval from the USFDA for Zolmitriptan Tablets USP

 

Other ANDA Approvals      

DRUG	COMPANY	Corresponding RLD
Memantine Hydrochloride	Apotex	Namenda (Allergan)
Neostigmine Methylsulfate	Dr Reddy	Bloxiverz (Avadel Legacy)

 

Tentative ANDA Approvals

DRUG	COMPANY	Corresponding RLD
Ticagrelor	Alembic	Brilinta (Astrazeneca)
Lacosamide	Aurobindo Pharma	Vimpat (UCB)
Ranolazine	Ajanta Pharma	Ranexa (Gilead)

 

New Inter Partes Review petitions filed

DRUG	Innovator	Petitioner	Patents challenged (Petition No.)
Tavaborole topical solution	Anacor	Mylan	US9566290 (IPR2018-01360) US9572823 (IPR2018-01361) *Previously Flatwing pharmaceuticals has also filed petitions for the same patents (Petitions instituted)

 

NEWS FROM EU

DRUG	COMPANY	NEWS
Inotersen	Akcea Therapeutics	Akcea and Ionis Announce Approval of TEGSED (inotersen) in the European Union

 

*For browsing official press releases click on the respective news item.

 

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