NEWS 21 DEC 2018

NEWS FROM USA

New Paragraph IV filing

DRUG	Dosage form	Corresponding RLD	Date of Submission	Type of Submission (Based on Date)
Carfilzomib (10 mg/vial)	Injection	Kyprolis	28 Nov 2018	Post NCE-1 submission for new strength
Nintedanib	Softgel Capsules	Ofev	15 Oct 2018	NCE-1

 

NDA Approvals                    

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
19 Dec 2018	Diclofenac Epolamine Shampoo (505(b)2 approval)	Institut Biochimique	Licart	Link
21 Dec 2018	Levetiracetam extended release (505(b)2 approval)	Sun Pharma	Elepsia XR	Link

 

505 (b) 2s in pipeline

Asenapine transdermal patch (Hisamitsu): Hisamitsu submits New Drug Application of Asenapine transdermal patch in the US.

 

Minocycline foam 4% (Foamix): Foamix Submits New Drug Application to U.S. FDA Seeking Approval of FMX101 in Treatment of Moderate-to-Severe Acne.

 

ANDA Approvals              

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
19 Dec 2018	Benzonatate Capsule	Puracap Pharma	Tessalon (Pfizer)	Ten
19 Dec 2018	Pramipexole Dihydrochloride Tablets	Unichem	Mirapex (Boehringer)	Fourteen
19 Dec 2018	Metoprolol Succinate ER Tablets	Twi Pharms	Toprol-Xl(Aralez)	Seven
19 Dec 2018	Potassium Chloride ER Tablets	Aurobindo	Klor-Con (Upsher)	Six

 

Tentative ANDA Approvals 

Approval Date	Drug	Company
19 Dec 2018	Alogliptin; Metformin Hydrochloride	Torrent

 

 

 

Other News from the USA

FDA publishes updated list of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (Link)

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