NEWS 02 JULY 2019

NEWS FROM USA

NEW GENERICS LAUNCHES IN US

LAUNCH DATE	DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
28 June 2019	Loteprednol Etabonate Ophthalmic Suspension	Akron Pharma	Lotemax (Bausch And Lomb)	$90 Million	Link
01 July 2019	1% sodium hyaluronate prefilled syringe	Teva	Euflexxa (Ferring)	N/A	Link

 

505(b)2 IN PIPELINE:

Tadalafil and finasteride fixed dose combination (Veru Inc): Veru Announces Successful Completion of Pre-NDA Meeting with FDA for TADFIN (Tadalafil 5 mg and Finasteride 5mg) Combination for the Treatment of Benign Prostatic Hyperplasia.

Press Release: Link

505(b)2 APPROVALS

Approval Date	Product Name	NDA Sponsor	Brand Name	Prescribing information
28 June 2019	Tiopronin Delayed Release Tablets	Mission Pharma	Thiola EC	Link

 

ANDA APPROVALS

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
24 June 2019	Penicillamine Capsules	Watson Labs	Cuprimine (Valeant Pharma)	One (Amerigen)
24 June 2019	Oseltamivir Phosphate Capsules	Alembic Pharms	Tamiflu (Roche)	Seven
24 June 2019	Daptomycin Powder	Accord Hlthcare	Cubicin (Cubist Pharms)	Six
25 June 2019	Dorzolamide Hydrochloride; Timolol Maleate Ophthalmic solution	Somerset Theraps	Cosopt (Oak Pharms)	Nine
26 June 2019	Dapsone Topical Topical	Taro Pharma	Aczone (Almirall)	None
26 June 2019	Tobramycin inhalation Solution (300MG/4ML)	Teva Phama	Bethkis (Chiesi)	None
26 June 2019	Daptomycin Power	Be Pharma	Cubicin (Cubist)	Seven
27 June 2019	Acetaminophen; Codeine Phosphate Tablets	Wes Pharma	None	Four
27 June 2019	Methylprednisolone Tablets	Sungen Pharma	Medrol (Pharmacia And Upjohn)	Nine
28 June 2019	Tramadol Hydrochloride Tablets	Rubicon	Ultram (Janssen Pharms)	More Than 10
28 June 2019	Cinacalcet Hydrochloride Tablets	Lupin Ltd	Sensipar (Amgen)	Nine
28 June 2019	Isoproterenol Hydrochloride Injection	Cipla	Isuprel (Bausch)	Four
28 June 2019	Ezetimibe and Simvastatin Tablets	Glenmark Pharma	Vytorin (MSD International)	Five
01 July 2019	Clonazepam Orally Disintegrating Tablets	Alembic pharma	Klonopin Orally Disintegrating Tablets (Hoffmann-La Roche Inc)	Three
01 July 2019	Febuxostat Tablets	Mylan Pharms	Uloric Tablets (Takeda)	Two
01 July 2019	Febuxostat Tablets	Alembic Pharms	Uloric Tablets (Takeda)	Two

*Highlighted products indicate first generic approval for corresponding RLD.

 

TENTATIVE ANDA APPROVALS

Approval Date	Drug	Company
19 June 2019	Lubiprostone	Amneal Pharms
19 June 2019	Ivermectin	Perrigo
19 June 2019	Clindamycin Phosphate	Glenmark Pharms
20 June 2019	Ketorolac Tromethamine	Micro Labs
21 June 2019	Roflumilast	Alkem Labs
24 June 2019	Apremilast	Annora
25 June 2019	Bortezomib	Dr Reddys
26 June 2019	Atorvastatin Calcium	Perrigo
26 June 2019	Mirabegron	Lupin Ltd
26 June 2019	Febuxostat	Msn Lab
26 June 2019	Dapagliflozin	Micro Labs
27 June 2019	Amphetamine Aspartate;Amphetamine Sulfate;Dextroamphetamine Saccharate;Dextroamphetamine Sulfate	Specgx Llc

 

USFDA INSPECTION

Alembic Pharma (Panelav facility): Alembic clears its first US FDA Inspection at Solid Oral Oncology facility at Panelav.

-         Alembic announced that USFDA has conducted an inspection at Company's Solid Oral Oncology facility located at Panelav from 24th June, 2019 to 28th June, 2019.

-         Inspection completed without any Form 483 Observation.

-         Press Release: Link

 

OTHER NEWS FROM USA

Bivalirudin (SunGen/Athenex): SunGen Pharma Announces to Partner with Athenex Pharmaceutical to Launch Bivalirudin through PIV Challenges in US.

-      The ANDA is exclusively licensed from the current ANDA holder, Hainan Shuangcheng Pharmaceuticals.

-      Full press release: Link

 

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