NEWS 29 DEC 2018

NEWS FROM USA

505 (b) 2s in pipeline

Tadalafil Sublingual Tablets (Adamis Pharma): Adamis pharama submits NDA application to the USFDA for its fast dissolving sublingual tadalafil tablets for the treatment of erectile dysfunction.

 

Dexmedetomidine Sublingual film (Bioxcel Therapetics): The U.S. FDA has granted Fast Track Designation for its investigational drug BXCL501 in the treatment of acute agitation

 

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Pimecrolimus cream 1%	Teva Pharma	Elidel	218.4 Mn USD	Link

         

ANDA Approvals                                                  

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
26 Dec 2018	Griseofulvin, Ultramicrosize Tablets	Sandoz	Gris-Peg (Valeant)	Two (Mountain, Sigmapharm)
26 Dec 2018	Azithromycin Tablets	Bionpharma	Zithromax (Pfizer)	Eight
26 Dec 2018	Clobetasol Propionate Cream	Amneal Pharms	N/A	Ten
27 Dec 2018	Cinacalcet Hydrochloride Tablets	Watson Labs	Sensipar (Amgen)	Seven
27 Dec 2018	Octreotide Acetate Injection	Usv North	Sandostatin (Novartis)	Six
27 Dec 2018	Pimecrolimus Cream	Actavis	Elidel (Valeant)	None
27 Dec 2018	Metformin Hydrochloride ER Tablets	Qingdao Baheal	Fortamet (Andrx Labs)	Four
27 Dec 2018	Clofarabine Solution	Hospira	Clolar (Genzyme)	Seven
29 Dec 2018	Clindamycin Phosphate And Benzoyl Peroxide Gel	Zydus	Duac (Stiefel)	Three

Highlighted product indicates first generic approval for the corresponding RLD.

 

Tentative ANDA Approvals 

Approval Date	Drug	Company
26 Dec 2018	Esomeprazole Magnesium; Naproxen	Dr Reddys
26 Dec 2018	Aripiprazole	Pharmtak
26 Dec 2018	Aripiprazole	Pharmtak
27 Dec 2018	Pregabalin	Aurobindo
27 Dec 2018	Pregabalin	Cadila

 

NEWS RELATED TO GENERIC PATENT LITIGATION

Methylphenidate XR-ODT (Cotempla XR-ODT): Neos Therapeutics Announces Settlement with Teva on Cotempla XR-ODT Patent Litigation

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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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NEWS 25 DEC 2018

NEWS FROM USA

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Aspirin and Extended-Release Dipyridamole Capsules	Dr Reddy’s	Aggrenox (Boehringer Ingelheim)	$182 Million	Link

         

ANDA Approvals                                                  

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
20 Dec 2018	Vecuronium Bromide Injection	Aurobindo	N/A	Seven
21 Dec 2018	Pramipexole Dihydrochloride Tablets	Unichem	Mirapex (Boehringer)	Fourteen
24 Dec 2018	Polyethylene Glycol 3350  & Electrolytes  Oral Solution	Strides Pharma	Golytely (Braintree Laboratories)	One (Novel Lab)
24 Dec 2018	Doxycycline Hyclate DR Tablets	Zydus	Doryx (Mayne Pharma)	Three

                                               

Tentative ANDA Approvals 

Approval Date	Drug	Company
20 Dec 2018	Methylphenidate	Teva Pharma
21 Dec 2018	Levothyroxine Sodium	Maia Pharms
21 Dec 2018	Pregabalin	Alembic
24 Dec 2018	Febuxostat	Zydus

 

 

 

 

 

 

 

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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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