NEWS 10 OCT 2018

NEWS FROM USA

ANDA Approvals 

 

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
09 Oct 2018	Bimatoprost Topical Solution	Hi-Tech Pharmacal	Latisse (Allergan)	Two (Apotex & Sandoz)
09 Oct 2018	Azithromycin Suspension	Aurobindo Pharma	Zithromax (Pfizer)	Six
09 Oct 2018	Dexmethylphenidate Hydrochloride Er Capsule	Adare Pharms	Focalin Xr (Novartis)	Four
09 Oct 2018	Cefixime Capsule	Alkem Labs	Suprax (Lupin)	None

*Highlighted products indicated FDA’s off patent off exclusivity drugs

 

Tentative ANDA Approvals           

Approval Date	Drug	Company
09 Oct 2018	Azithromycin Injection	Hainan Poly Pharma

 

NEW GENERICS LAUNCHES IN US

 

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Colesevelam Hcl Tablets	Dr Reddy	Welchol (Daiichi Sankyo)	$471 Mn	Link

 

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