NEWS 27 DEC 2018

NEWS FROM USA

NDA Approvals                    

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
21 Dec 2018	Levodopa Powder	Acorda	Inbrija	Link

 

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Sevelamer Carbonate Oral suspension	Dr Reddy’s	Renvela (Sanofi)	$101 Million	Link

         

ANDA Approvals                                                  

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
21 Dec 2018	Loratadine Capsules	Bionpharma	Claritin (Bayer)	One (Marksans)
21 Dec 2018	Bretylium Tosylate Injection	Academic	Bretylium Tosylate (Hospira)	Seven
21 Dec 2018	Tigecycline Powder	Apotex	Tygacil (PF Prism)	Three
21 Dec 2018	Atorvastatin Calcium Tablets	Thepharmanetwork	Lipitor (Pfizer)	Twelve
21 Dec 2018	Phenylephrine Hydrochloride Solution	Par Sterile	Vazculep (Avadel)	Three
21 Dec 2018	Desoximetasone Cream	Riconpharma	N/A	Three

 

Tentative NDA Approvals 

Approval Date	Drug	Company
21 Dec 2018	Buprenorphine Er Injection	Braeburn

 

 

 

 

Tentative ANDA Approvals 

Approval Date	Drug	Company
21 Dec 2018	Solifenacin Succinate	Qilu Pharm
21  Dec 208	Treprostinil	Par Sterile

 

 

 

 

 

Other news from the USA

FDA Approves VAXELIS, Sanofi and MSD’s Pediatric Hexavalent Combination Vaccine

 

 

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