NEWS 29 NOV 2018

NEWS FROM USA

NDA Approvals        

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
29 Nov 2018	Amifampridine	Catalyst Pharma	Firdapse	Label
28 Nov 2018	Gilteritinib Tablets	Astellas	Xospata	Label

 

ANDA Approvals 

 

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
27 Nov 2018	Aminocaproic Acid Tablets	Sunny Pharmtech	Amicar (Clover Phama)	This product was mentioned in FDA’s off patent off exclusivity product with no generic list
29 Nov 2018	Lansoprazole orally disintegrating delayed release Tablets	Zydus	Prevacid (Takeda)	One

 

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Epinephrine Injection	Teva	Mylan (Epipen)	N/A	Link

                            

Tentative ANDA Approvals

 

Approval Date	Drug	Company
29 Nov 2018	Linagliptin Tablets	Zydus

 

 

NEWS FROM EUROPE

Final Approval from the EMA

Drug	Sponsor	Indication
Fingolimod (New patient population for MS; New strength 0.25 mg)	Novartis	Treatment of children and adolescents 10 to 17 years old with relapsing-remitting forms of multiple sclerosis (RRMS)
Doravirine / lamivudine / tenofovir disoproxil fumarate & Doravirine	Merck	Treatment of HIV-1

 

                                               

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NEWS 28 NOV 2018

NEWS FROM USA

ANDA Approvals 

 

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
28 Nov 2018	Venlafaxine hydrochloride ER capsules	Intellipharma	Effexor XR (Wyeth Pharma)	Ten
27 Nov 2018	Tenofovir Disoproxil Fumarate	Mylan	Viread (Gilead)	Nine

 

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Chlorthalidone Tablets	Dr Reddy	Hygroton (Sanofi)	$122 Million	Link
Diclofenac Sodium Gel	Perrigo	Solaraze (Fougera)	$31 Million	Link

                            

Tentative ANDA Approvals

 

Approval Date	Drug	Company
26 Nov 2018	Cinacalcet Tablets	Zydus

 

News Related To Generic Patent Litigations

Betamethasone Dipropionate, 0.05% sprays (Perrigo): Perrigo Announces Patent Litigation Settlement For The Generic Version Of Sernivo Spray, 0.05%

Other news from the USA

Pregabalin: Pfizer Receives Six Months Pediatric Exclusivity For Lyrica (Pregabalin)                                            

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NEWS 27 NOV 2018

NEWS FROM USA

NDA Approvals        

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
26 Nov 2018	Larotrectinib Capsules	Loxo	Vitrakvi	Label
26 Nov 2018	Larotrectinib Oral Solution	Loxo	Vitrakvi	Label

 

505(b)2  products in pipeline

Riluzole sublingual, oral disintegrating tablet (Biohaven): Biohaven Announces FDA Acceptance of 505(b)(2) NDA Filing for Riluzole for the Treatment of Amyotrophic Lateral Sclerosis

ANDA Approvals 

 

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
27 Nov 2018	Temazepam Capsules	Alembic	Restoril (Specgx)	Five
26 Nov 2018	Lidocaine Ointment	Alembic	Xylocaine (Astrazeneca)	Ten
26 Nov 2018	Diclofenac Sodium Topical Gel	Akorn	VOLTAREN (NOVARTIS)	Four
23 Nov 2018	Eptifibatide Injection	Celerity Pharms	Integrilin (Schering)	Seven
23 Nov 2018	Lactulose Oral Solution	Lifepharma	N/A	Ten
23 Nov 2018	Triamcinolone Acetonide Ointment	Macleods	Triamcinolone Acetonide (Mylan)	Three
23 Nov 2018	Potassium Chloride Oral Solution	Epic Pharma	Potassium Chloride (Pharma Res)	Two (Upsher, Novel)
23 Nov 2018	Ibuprofen Suspension	Aptapharma	Children's Motrin (J And J Consumer)	Nine
23 Nov 2018	Ranitidine Capsule	Novitium	N/A	N/A
23 Nov 2018	Leucovorin Calcium Injection	Ingenus	N/A	Two (Fresenius, West Ward)
23 Nov 2018	Lidocaine Ointment	Aleor	N/A	Ten
23 Nov 2018	Baclofen Tablets	Zydus	N/A	Eleven

                            

USFDA inspections

Lupin's Tarapur facility receives EIR from US FDA

 

NEWS FROM EUROPE

Final approval from (EMA)

Drug	Sponsor	Indication
Pegfilgrastim	Sandoz	Neutropenia and febrile neutropenia in adult cancer patients treated with chemotherapy

 

 

                                                                                                                                                                                                                                                                   

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NEWS 26 NOV 2018

NEWS FROM USA

NDA Approvals        

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
21 Nov 2018	Glasdegib Tablets	Pfizer	Daurismo	Label
21 Nov 2018	Indocyanine green IV	Novadaq technology	Spy agent green	Label

 

Supplement NDA approvals

Venetoclax indication expansion: AbbVie Receives US FDA Accelerated Approval for VENCLEXTA® (venetoclax) for Treatment of Newly-Diagnosed Acute Myeloid Leukemia Patients Ineligible for Intensive Chemotherapy

505(b)2  products in pipeline

Rizatriptan oral films (IntelGenx): IntelGenx announces fda’s acceptance of resubmission of new drug application for Rizaport (PDUFA date: 1 Apr. 2019)

Paclitaxel Injection Concentrate for Suspension (Sun Pharma, 505 (b) 2 of Abraxane): SPARC Announces Top-line Results of Pivotal Bioequivalence Study for Paclitaxel Injection Concentrate for Suspension

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Abiraterone tablets	Apotex	Zytiga (Janssen)	N/A	Link

 

ANDA Approvals 

 

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
19 Nov 2018	Heparin Sodium Injection	Sterinova	Heparin Sodium (Pfizer)	N/A
20 Nov 2018	Dyclonine Hydrochloride Solution	Novocol	Dyclone (Astrazeneca)	None
20 Nov 2018	Buprenorphine  ER Transdermal	Watson	Butrans (Purdue)	None
20 Nov 2018	Atorvastatin Calcium Tablets	Zydus	Lipitor (Pfizer)	Eleven
20 Nov 2018	Levocetirizine Dihydrochloride Tablets	Micro	Xyzal Allergy 24hr (Sanofi)	One (Dr Reddy)
21 Nov 2018	Atovaquone Oral Suspension	Glenmark	Mepron (GSK)	Four
21 Nov 2018	Calcitriol solution	Invatech	Rocaltrol (Validus)	One
21 Nov 2018	Potassium chloride oral solution	Novel (Lupin)	Potassium chloride (Pharma Res software)	None
21 Nov 2018	Methylphenidate ER tablets	Granules	None	Four
21 Nov 2018	Fluoxetine tablets	Appco pharma	Fluoxetine (Alvogen)	Three
21 Nov 2018	Clomipramine Capsules	Lupin	Anafranil (Specgx)	Six
23 Nov 2018	Roflumilast tablets	Hetero	Daliresp (Astra Zeneca)	Three

 

Tentative ANDA Approvals

 

Approval Date	Drug	Company
20 Nov 2018	Halobetasol Propionate	Perrigo
21 Nov 2018	Dimethyl Fumarate	Zydus
23 Nov 2018	Clobetasol emulsion foam	Glenmark

 

 

USFDA inspections

Indoco’s Goa Plant II & III clears USFDA inspection

 

 

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