NEWS 10 APR 2019

NEWS FROM USA

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Fluoxetine Tablets	Lupin	Fluoxetine Hydrochloride	N/A	Link

 

NDA Approvals

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
08 Apr 2019	Dolutegravir;Lamivudine Tablets	Viiv Hlthcare	Dolutegravir;Lamivudine	Link

 

ANDA Approvals

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
05 Apr 2019	Ketorolac Tromethamine  Solution	Micro Labs	Acular (Allergan)	Four
05 Apr 2019	Thiothixene Capsule	Novitium	Navane (Pfizer)	Mylan
05 Apr 2019	Ranitidine Hydrochloride Capsule	Appco	Zantac (GSK)	Four
08 Apr 2019	Tetrabenazine Tablets	West-Ward	Xenazine (Valeant)	Five
08 Apr 2019	Clomipramine Hydrochloride Capsule	Mankind Pharma	Anafranil (Specgx)	Eight
10 Apr 2019	Decitabine Injection	Wockhardt	Dacogen (Otsuka)	Eight

 

Tentative ANDA Approvals

Approval Date	Drug	Company
08 Apr 2019	Icatibant	Teva Pharms

 

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