NEWS 28 SEP 2018

NEWS FROM USA

NDA Approvals        

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
27 Sep 2018	Dacomitinib Tablets	Pfizer	Vizimpro	Label
27 Sep 2018	Galcanezumab-Gnlm Injection	Eli Lilly And Co	Emgality	Label

 

New Strength Approval For Existing NDA

 

Approval Date	Drug	NDA Sponsor	Brand Name	Strength
27 Sep 2018	Epinephrine	Adamis Pharms	Symjepi	0.15 mg for paediatric use

 

ANDA Approvals

           

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
26 Sep 2018	Acetaminophen; Butalbital; Caffeine Capsule	Aurolife Pharma	N/A	One (Mayne Pharma)
26 Sep 2018	Ibuprofen Suspension	Guardian	Children's Motrin (J And J Consumer Inc)	Two (L Perrigo And Tris Pharma)
26 Sep 2018	Acetaminophen; Butalbital; Caffeine Tablets	Abhai Llc	N/A	Seven
26 Sep 2018	Amphetamine Sulfate Tablets	Amneal Pharms	EVEKEO (Arbor)	None

*For more details on ANDA approvals click on the Drug Product Name 

*Highlighted product has received Competitive Generic Therapy designation

 

Planned ANDA submission with granted Competitive Generic Therapy designation

Drug Product	ANDA Sponsor	Comment	Source of Information / Link
Minocycline Hydrochloride Microspheres 1 mg	Profounda Inc.	USFDA granted CGT designation for planned ANDA submission	PR Newswire Link

 

Tentative ANDA Approvals           

Approval Date	Drug	Company
25 Sep 2018	Tofacitinib	Prinston Pharma
26 Sep 2018	Linagliptin; Metformin Hydrochloride	Msn Labs Pvt

 

NEW GENERICS LAUNCHES IN US

 

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Tadalafil Tablets (Cialis)	Teva (Will be lone generic player for first 180 days)	Cialis (Lilly)	$1.93 Billions	Link

 

 

New Paragraph IV filing

DRUG	Dosage form	Corresponding RLD	Date of Submission	Type of Submission (Based on Date)
Empagliflozin	Tablets	Jardiance	01 Aug 2018	NCE-1
Empagliflozin And Metformin Hydrochloride	Tablets	Synjardy	01 Aug 2018	NCE-1
Empagliflozin And Metformin Hydrochloride	Extended-Release Tablets	Synjardy XR	01 Aug 2018	NCE-1
Empagliflozin And Linagliptin	Tablets	Glyxambi	01 Aug 2018	NCE-1
Deoxycholic Acid	Injection	Kybella	13 July 2018	NCE-1
Morphine Sulphate And Naltrexone Hydrochloride (20 Mg/0.8 Mg)	Extended-Release Capsules	Embeda	16 Aug 2018	Open filing
Tavaborole	Topical Solution	Kerydin	9 July 2018	NCE-1

 

Now, you can also follow us on twitter @pharmacaptions. If you have any query/suggestion then please write us at pharmacaption@gmail.com

 

 

 

 

 

NEWS 26 SEP 2018

NEWS FROM USA

ANDA Approvals

           

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
24 Sep 2018	Azithromycin Tablets	Cspc Ouyi Pharm	Zithromax (Pfizer)	Six
24 Sep 2018	Metaxalone Tablets	Appco Pharma	Skelaxin (King Pharma)	Five
24 Sep 2018	Olanzapine Tablets	Jiangsu Hansoh	Zyprexa (Lilly)	Thirteen
24 Sep 2018	Doxycycline Hyclate Capsule	Ajanta Pharma	Vibramycin (Pfizer)	Eight

*For more details on ANDA approvals click on the Drug Product Name 

 

 

Now, you can also follow us on twitter @pharmacaptions. If you have any query/suggestion then please write us at pharmacaption@gmail.com

 

 

 

 

 

NEWS 25 SEP 2018

NEWS FROM USA

NDA Approvals        

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
24 Sep 2018	Duvelisib Capsule	Verastem	Copiktratm	Label

         

ANDA Approvals     

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
21 Sep 2018	Efavirenz Tablets	Aurobindo	Sustiva (BMS)	Five
21 Sep 2018	Albendazole Tablets	Cipla	Albenza (Impax Labs)	None
24 Sep 2018	Atazanavir Sulfate Capsule	Mylan	Reyataz (BMS)	Three
24 Sep 2018	Metformin Hydrochloride ER Tablets	Yichang Humanwell	Glucophage XR (BMS)	Nineteen

*For more details on ANDA approvals click on the Drug Product Name 

Highlighted product indicates first US generic for respective RLD.

 

Tentative ANDA Approvals           

Approval Date	Drug	Company
24 Sep 1018	Topiramate extended release capsules (Corresponding RLD: Trokendi XR)	Par Pharm

 

 

Other News from US

 

FDA publishes Final Guidance on ANDA submissions – content and format

 

Gilead Subsidiary to Launch Authorized Generics of Epclusa® (Sofosbuvir/Velpatasvir) and Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C (Combined quarterly sales of these products: 831 Mn $)

 

 

NEWS FROM EUROPE

Positive CHMP opinions (EMA)

Drug	Sponsor	Indication
Galcanezumab	Lilly	Prophylaxis of Migraine
Enzalutamide	Astellas	non-metastatic castration-resistant prostate cancer (nmCRPC)
Venetoclax  in combination with Rituximab	Abbvie	Chronic Lymphocytic Leukemia
fluticasone furoate/umeclidinium/vilanterol	Theravance	moderate to severe chronic obstructive pulmonary disease (COPD)

CHMP positive opinion is one of the final steps before a final decision on the regulatory update is granted by the European Commission.

New Authorizations

European Commission approves Imfinzi for locally-advanced, unresectable NSCLC

Now, you can also follow us on twitter @pharmacaptions. If you have any query/suggestion then please write us at pharmacaption@gmail.com

 

 

 

 

 

NEWS 21 SEP 2018

NEWS FROM USA

ANDA Approvals     

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
18 Sep 2018	Levonorgestrel Tablets	Apotex	Plan B One-Step	Twelve
19 Sep 2018	Tetracycline Hydrochloride Capsule	Amneal	Achromycin V (Heritage Pharma)	Two (Chartwell & Watson)
19 Sep 2018	Palonosetron Hydrochloride Injection	Sagent	Aloxi (Helsinn Hlthcare)	Eleven. (First Filier’s Patent Challenge Exclusivity Expired On 19 Sep. 2018
19 Sep 2018	Palonosetron Hydrochloride Injection	Qilu Pharm
19 Sep 2018	Palonosetron Hydrochloride Injection	Cipla
19 Sep 2018	Palonosetron Hydrochloride Injection	Mylan
19 Sep 2018	Palonosetron Hydrochloride Injection	Fresenius
19 Sep 2018	Palonosetron Hydrochloride Injection	Fresenius
19 Sep 2018	Palonosetron Hydrochloride Injection	Hospira
19 Sep 2018	Palonosetron Hydrochloride Injection	Virtus
19 Sep 2018	Aripiprazole Tablets	Mylan	Abilify (Otsuka)	Fourteen
19 Sep 2018	Dexmethylphenidate Hydrochloride Tablets	Cediprof	Focalin (Novartis)	Seven
21 Sep 2018	Busulfan Injection	Sandoz	Busulfex (Otsuka )	Seven

*For more details on ANDA approvals click on the Drug Product Name

 

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Dalfampridine ER Tablets (Authorized Generic)	Mylan	Ampyra (Acorda)	$553	Link

 

NEWS FROM EUROPE

Sandoz receives positive CHMP opinion for proposed biosimilar pegfilgrastim

Novartis receives positive CHMP opinion for Gilenya for the treatment of children and adolescents with MS, marking a major medical advance for young MS patients in Europe

Novartis announces positive CHMP opinion for one-time gene therapy Luxturna to treat children and adults with rare inherited retinal disease

Sun Pharma Announces Receipt of European Commission Approval For ILUMETRI (tildrakizumab) By Almirall For Treatment Of Moderate-To-Severe Chronic Plaque Psoriasis

Valsartan: review of impurities extended to other sartan medicines

Mylan and Biocon Announce Positive CHMP Opinion for Fulphila, Biosimilar Pegfilgrastim

 

Now, you can also follow us on twitter @pharmacaptions. If you have any query/suggestion then please write us at pharmacaption@gmail.com