NEWS 21 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
19 July 2019	Fexofenadine HCL and Pseudoephedrine ER tablets (OTC)	Dr. Reddy’s laboratories (DRL)	Allegra-D (Aventisub II)	$44 Million	Link
19 July 2019	Pregabalin Capsules	Rising Pharma	Lyrica	$5497 Million	Link

 

505(b)2 in pipeline

Riluzole sublingual tablet (Biohaven): Biohaven Pharma received a CRL from the FDA for the 505(b)2 application seeking approval for Riluzole (NURTEC) for ALS.

-         The sole issue identified in the CRL relates to an FDA concern regarding the use of API that was manufactured by Apotex pharma between 2014 to 2016 and used in the drug product supplies for the bioequivalence study in 2017.

-         As per Biohaven, the API for commercial supply of Nurtec (riluzole) is currently sourced from another supplier, with whom no CMC issues have been identified.

-         Concern with Apotex manufacturing recently led to the withdrawal of 31 Apotex drug products from the US market last Wednesday, July 10th 2019

-         Press release: Link

 

 

NDA Approval

Approval Date	Product Name	NDA Sponsor	Brand Name	Prescribing information
16 July 2019	Imipenem;Cilastatin;Relebactam Injection	Merck Sharp	Recarbrio	Link

 

505(b)2 Approval

Approval Date	Product Name	NDA Sponsor	Brand Name	Prescribing information
18 July 2019	Zinc Sulfate Injection	American Regent	Zinc Sulfate	Link

 

Zinc Sulfate injection was previously marketed as unapproved product in the US by American Regent. For American Regent, this is the second 505(b)2 approval of the  unapproved product in the span of three months. Earlier they received 505(b)2 approval of Selenious acid in the month of April.

 

Summary on American Regent’s Zinc Sulfate injection

Strengths: 3 mg/ml an 5 mg/ml

Indication: Source of zinc for parenteral nutrition

Packaging: Glass vials

Storage: Controlled Room temperature USP

 

GENERIC PATENT LITIGATION

Methylnaltrexone bromide - Relistor^® (Bausch health v. Actavis):

-      The District court of New Jersey decides in favour of Bausch health in the patent infringement case related to generic Relistor^®.

-      The decision means Teva’s generic version will be blocked until March 2031.

-      Full Press Release: Link

 

ANDA APPROVALS

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
12 July 2019	Technetium TC-99m Mertiatide Kit Injection#	Pharmalucence	Technescan Mag3 (Curium)	None
12 July 2019	Isosulfan Blue Injection	Somerset Theraps	Lymphazurin (Covidien)	Three
12 July 2019	Ethacrynic Acid Tablets	Agnitio	Edecrin (Bausch)	Five
12 July 2019	Daptomycin Powder 350 mg/vial*	Accord Hlthcare	Daptomycin (Sagent)	None
15 July 2019	Icatibant Acetate Injection	Teva Pharma	Firazyr (Shire Orphan)	None
16 July 2019	Dactinomycin injectable	Hisun	Cosmegen (Recordati)	Two
19 July 2019	Pregabalin capsules	Amneal DRL Sciegen MSN Rising Invagen	Lyrica (Pfizer)	None

Highlighted products indicate first generic approval for corresponding RLD.

*#These products were mentioned in the FDA’s latest off-patent off-exclusivity products without an approved generic list.

 

TENTATIVE ANDA APPROVALS

Approval Date	Drug	Company
12 July 2019	Sildenafil	Alkem Labs
12 July 2019	Ivermectin	Teva Pharms
16 July 2019	Everolimus	West-Ward Pharms
16 July 2019	Enzalutamide	Eugia Pharma
16 July 2019	Gefitinib	Cipla Ltd

 

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