NEWS 05 FEB 2019

NEWS FROM USA

ANDA Approvals                                                  

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
1 Feb. 2019	Methylphenidate hydrochloride	Cediprof	Ritalin	More than 10
1 Feb. 2019	Baclofen tablets	Eywa pharm	N/A	More than 10
1 Feb. 2019	Dicyclomine injection	Nexus pharma	Bentyl	Six
1 Feb. 2019	Oxycodone oral solution	Pharma Assoc	N/A	N/A

 

Tentative ANDA Approvals 

Approval Date	Drug	Company
1 Feb. 2019	Pregabalin	Alkem
1 Feb. 2019	Apixaban	Micro labs
4 Feb. 2019	Dapagliflozin	Teva
4 Feb. 2019	Febuxostat	Torrent

 

 

NEW GENERICS LAUNCHES IN THE US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Clomipramine hydrochloride capsules	Lupin	Anafranil (Specgx)	$ 96.2 millions	Link

 

GENERIC PATENT LITIGATION

Generic Suboxone (Dr. Reddy’s) Court of Appeals for the Federal Circuit (CAFC) Denies Motion for Rehearing or Rehearing En Banc Following the CAFC’s Ruling Vacating the Preliminary Injunction Granted against Dr. Reddy’s Laboratories

 

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