NEWS 13 JUNE 2019

NEWS FROM USA

505(b)2 IN PIPELINE

Naloxone Pre-Filled Single Dose Syringe (Adamis Pharma):  USFDA acknowledged the receipt of Adamis Pharma’s amendment to its previously submitted NDA of Naloxone Pre-Filled Single Dose Syringe.

-      The amendment removed EVZIO^® as a Reference Listed Drug (RLD) and withdrew the associated Paragraph IV certification.

-      Adamis said that Narcan injectable (NDA 016636) now remains as the sole RLD for its (b)2 NDA and, because there are no Orange Book listed patents for NDA 016636, no patent certification is required.

-      With this change, Adamis opined that the amended NDA will not be subject to a 30-month stay and that the FDA will be free to issue an approval as soon as the agency completes a satisfactory review of the Adamis naloxone NDA.  

-      Full Press Release: Link

 

ANDA APPROVALS

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
04 June 2019	Ranolazine ER Tablets	Sciegen Pharms	Ranexa (Gilead)	Five
05 June 2019	Esomeprazole Magnesium DR Capsules	Amneal Pharms	Nexium 24hr (Astrazeneca)	Three
05 June 2019	Carbidopa; Levodopa ER Tablets	Alembic Pharms	Sinemet CR (Merck Sharp)	Five
06 June 2019	Desmopressin Acetate Tablets	Novast Labs	Ddavp (Ferring)	Seven
07 June 2019	Dexamethasone Sodium Phosphate Injection	Aurobindo Pharma	Hexadrol (Aspen)	Eight
10 June 2019	Niacin ER Tablets	Yichang Humanwell	Niaspan (Abbvie)	Seven
12 June 2019	Mesalamine Rectal Suppository	Sandoz	Canasa (Allergan)	Two

 

TENTATIVE ANDA APPROVALS

Approval Date	Drug	Company
03 June 2019	Erlotinib	Apotex
07 June 2019	Tofacitinib	Breckenridge

 

GENERIC PATENT LITIGATIONS

Mifepristone tablets 300 mg - Korlym (Sun Pharma): Corcept has received a Para IV Notice Letter advising that Sun Pharma submitted an ANDA to the USFDA seeking authorization from the FDA to manufacture, use or sell a generic version of KORLYM^® Mifepristone Tablets, 300 mg in the US.

-      Full Press Release: Link

 

USFDA INSPECTIONS

Cipla (Kurkumbh manufacturing facility): Cipla provided update on USFDA inspection at company’s Kurkumbh manufacturing facility

-      Full Press Release: Link

 

OTHER NEWS FROM USA

Amifampridine (Catalyst pharma): Catalyst Pharma (NDA holder of Firdapse) sues FDA over approval of cheaper rival drug (Ruzurgi).

-      The lawsuit alleges that the approval of Ruzurgi, a rival drug from privately held Jacobus Pharmaceutical Co, in May violated provisions of FDA regulations and Catalyst’s rights to orphan drug exclusivity for its drug, Firdapse.

-      Both drugs are approved to treat Lambert-Eaton myasthenic syndrome, but Firdapse was approved for adults, while Jacobus’ drug was for children. But Catalyst suspects that the unexpected approval of Ruzurgi potentially enables adults to use it off-label, which would likely erode Firdapse’s market share.

-      Firdapse treatment is priced at at $375,000 a year, while Jacobus’ treatment is priced at less than half that cost, at about $175,200 annually.

-       Full Press Release: Link

 

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