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

 

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NEWS 28 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
24 July 2049	Ramelteon Tablets	Zydus	Rozerem (Takeda Pharma)	$91.3 Million	Link
23 July 2019		Dr. Reddy’s laboratories (DRL)			Link
22 July 2019	Pregabalin capsules	Amneal	Lyrica (PF Prism)	$5.4 Million	Link
19 July 2019	Busulfan	Apotex Pharma	Busulfex (Otsuka pharma)	N/A	Link

 

 

NDA APPROVALS

New formulation approvals

Approval Date	Product Name	NDA Sponsor	Brand Name	Comments
24 July 2019	Glucagon inhalation powder	Eli lilly	Baqsimi	Previously Glucagon was available only as injectable formulation.   Baqsimi is the first glucagon therapy approved for the emergency treatment of the condition, without using an injection.   Label|FDA Approval letter| FDA Press release
19 July 2019	Duloxetine DR sprinkle Capsules (505(b)2)	Sun Pharma	Drizalma sprinkle	Currently marketed Duloxetine is available as delayed release capsule that is required to be taken as whole, while Drizalma Sprinkle may be opened and sprinkled over applesauce; or administered via nasogastric tube.     Label|FDA Approval letter
25 July 2019	Bivalirudin Ready-to-use solution (505(b)2)	Maia pharma	Angiomax RTU	Currently Bivalirudin is available as lyophilized powder and premix solution (250mg/50ml; 500mg/100ml). Bivalirudin premix solution is marketed by Baxter in their Galaxy plastic container which is stored at frozen temperature.   Angiomax RTU also contains the same strength (250mg/50ml) that is marketed by Baxter.   FDA Approval letter

 

New molecular entity approval

Approval Date	Product Name	NDA Sponsor	Brand Name	Comments
25 July 2019	Ferric maltol capsules	Shield UK	Accrufer	Iron replacement product approved for the treatment of iron deficiency in adults. This product is already approved in European union and Switzerland.   Label|FDA Approval letter| Shield Press Release

 

ANDA APPROVALS

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
17 July 2019	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsules ER	Nesher Pharma	Adderall XR 5 (Shire)	Nine
17 July 2019	Tranexamic Acid Injection	Caplin	Cyklokapron (Pharmacia And Upjohn)	More Than 10
17 July 2019	Tranexamic Acid Injection	Apollo Pharma
18 July 2019	Olmesartan Medoxomil Tablets	Umedica Labs	Benicar (Daiichi Sankyo)	More Than 10
18 July 2019	Choline Fenofibrate Capsules DR	Graviti Pharma	Trilipix (Abbvie)	Six
19 July 2019	Dexmethylphenidate Hydrochloride Tablets	Alkem Labs	Focalin (Novartis)	Six
19 July 2019	Pregabalin Capsules	Teva Alembic Alkem	Lyrica (PF Prism)	Eight
19 July 2019	Pregabalin Solution (20 mg/ml)	Alkem Labs	Lyrica (PF Prism)	None
22 July 2019	Morphine Sulfate Tablets	Upsher Smith	Morphine Sulfate (Hikma)	None
22 July 2019	Ramelteon Tablets	Zydus Pharms	Rozerem (Takeda)	Two (Actavis, Dr Reddys)
23 July 2019	Drospirenone; Ethinyl Estradiol Tablets	Sun Pharm	Yaz (Bayer Hlthcare)	More Than 10
23 July 2019	Fulvestrant Injection	Mylan	Faslodex (Astrazeneca)	Two (Amneal, Sandoz)
24 July 2019	Nystatin topical cream	Torrent	N/A	Seven

Highlighted product was mentioned in FDA’s off-patent off-exclusivity products without an approved generic list.

 

TENTATIVE ANDA APPROVALS

Approval Date	Drug	Company
17 July 2019	Dapagliflozin	Sandoz
19 July 2019	Erlotinib	Sun Pharma
19 July 2019	Dapagliflozin	Alembic Pharms
19 July 2019	Apremilast	Amneal Pharms

 

OTHER NEWS FROM THE USA

Pfizer nears deal to combine Off-Patent drug business With Mylan.

Full story: Wallstreet Journal

 

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