NEWS 12 FEB 2019

NEWS FROM USA

NEW GENERICS LAUNCHES IN THE US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Tadalafil Tablets	DR Reddys	Adcirca (Eli Lilly)	$490 Million	Link
Tadalafil Tablets	Lupin	Adcirca (Eli Lilly)	$474.3 Million	Link
Fluticasone Propionate And Salmeterol Inhalation Powder	Mylan	Advair Diskus (GSK)	N/A	Link

 

ANDA Approvals                                                  

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
06 Feb 2019	Ethinyl Estradiol; Levonorgestrel Tablets	Sun Pharm	Seasonale (Teva Branded)	Eight
06 Feb 2019	Nalbuphine Hydrochloride Injection	Mylan	N/A	Three
06 Feb 2019	Oxybutynin Chloride Tablets	Invatech	N/A	Seven
07 Feb 2019	Carbamazepine ER Tablets	Zydus	Tegretol-XR (Novartis)	One (Taro)
07 Feb 2019	Hydrochlorothiazide; Olmesartan Medoxomil Tablets	Accord Hlthcare	Benicar HCT (Daiichi)	Six
11 Feb 2019	Sevelamer Hydrochloride Tablets	Glenmark Pharma	Renagel (Genzyme)	N/A
12 Feb 2019	Fluoxetine Tablets	Lupin	Fluoxetine  (Alvogen)	Six

 

Tentative ANDA Approvals 

Approval Date	Drug	Company
07 Feb 2019	Desvenlafaxine	Intellipharmaceutics
07 Feb 2019	Fingolimod	Aurobindo Pharma
08 Feb 2019	Doxycycline	Amneal
08 Feb 2019	Apixaban	Sunshine
08 Feb 2019	Estradiol	Amneal
08 Feb 2019	Deferiprone	Taro Pharm

 

USFDA Inspection

USFDA issues 11 observations to DR Reddy’s Formulations Manufacturing Plant at Bachupally in Hyderabad

U.S. FDA completes inspection of Lupin’s Goa facility

 

NEWS FROM EUROPE

Lenalidomide generic launch in Central and Eastern Europe: Alvogen announced the launch of the first generic equivalent of Revlimid in Europe

 

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