NEWS 25 DEC 2018

NEWS FROM USA

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Aspirin and Extended-Release Dipyridamole Capsules	Dr Reddy’s	Aggrenox (Boehringer Ingelheim)	$182 Million	Link

         

ANDA Approvals                                                  

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
20 Dec 2018	Vecuronium Bromide Injection	Aurobindo	N/A	Seven
21 Dec 2018	Pramipexole Dihydrochloride Tablets	Unichem	Mirapex (Boehringer)	Fourteen
24 Dec 2018	Polyethylene Glycol 3350  & Electrolytes  Oral Solution	Strides Pharma	Golytely (Braintree Laboratories)	One (Novel Lab)
24 Dec 2018	Doxycycline Hyclate DR Tablets	Zydus	Doryx (Mayne Pharma)	Three

                                               

Tentative ANDA Approvals 

Approval Date	Drug	Company
20 Dec 2018	Methylphenidate	Teva Pharma
21 Dec 2018	Levothyroxine Sodium	Maia Pharms
21 Dec 2018	Pregabalin	Alembic
24 Dec 2018	Febuxostat	Zydus

 

 

 

 

 

 

 

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