NEWS 31 JULY 2019

NEWS FROM USA

NEW GENERICS LAUNCHES IN US

LAUNCH DATE	DRUG	Marketer	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
30 July 2019	Pregabalin capsules	Dr Reddys	Lyrica (PF Prism)	$5.4 Million	Link
30 July 2019	Nadolol tablets	Beximco	Corgard (Bayer)	$63 Million	Link

 

 

NDA APPROVALS

New chemical entity approval

Approval Date	Product Name	NDA Sponsor	Brand Name	Comments
30 July 2019	Darolutamide oral tablets	Bayer Healthcare	Nubeqa	Darolutamide is a non-steroidal androgen receptor inhibitor (ARi) (Currently available other Non-steroidal ARi’s include Enzaltamide and Apalutamide)   Indication: non-metastatic castration-resistant prostate cancer (nmCRPC)  Strength: 300 mg   Bayer has also filed for approval of Darolutamide in the European Union (EU), Japan and with other health authorities.   Prescribing information | Press release

 

ANDA APPROVALS

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
25 July 2019	Clotrimazole Solution	Tasman	Mycelex (Bayer Healthcare)	Three
25 July 2019	Choline Fenofibrate Dr Capsules	Aurobindo	Trilipix (Abbvie)	Seven
26 July 2019	Nicotine Polacrilex Troche Lozenge	Teva	Nicorette (Gsk)	Six
26 July 2019	Emtricitabine; Tenofovir Disoproxil Fumarate Tablets	Laurus Labs	Truvada (Gilead)	Three
29 July 2019	Piperacillin Sodium; Tazobactam Sodium Injection	Astral	Zosyn (Wyeth)	Ten

 

TENTATIVE ANDA APPROVALS

Approval Date	Drug	Company
29 July 2019	Ticagrelor	B Braun
29 July 2019	Cinacalcet	Accord Hlthcare

 

OTHER NEWS FROM THE USA

Dasotraline (Sunovion): The Food and Drug Administration (FDA) has accepted to review the New Drug Application (NDA) for dasotraline (Sunovion) in the treatment of binge eating disorder.

-         Dasotraline is a novel dopamine and norepinephrine reuptake inhibitor.

-         FDA has set PDUFA date May 14, 2020.

-         Press Release: Link

USFDA INSPECTIONS

Granules Pharma (Bonthapally facility): Granules India’s Bonthapally facility completed US FDA inspection.

-         Company’s Bonthapally facility located at Hyderabad, has completed the US FDA inspection from 22 July 2019 to 26 July 2019 with one (1) 483 observation which is procedural in nature.

-         The Company will respond to this observation within the stipulated time period.

-         Press Release: Link

Shilpa Medicare (Raichur Facility): Shilpa Medicare gets 5 observations from USFA for its Raichur Facility.

 

-         Company’s raichur facility has completed USFDA audit between 22nd July 2019 and 26th July 2019.

-         Company has received Form 483 with 5 observations, with no repeat observations and any data integrity observations.

-         The observations are mostly procedural in nature.

-         Press Release: Link

 

If you have any query/suggestion then please write us at pharmacaption@gmail.com