NEWS 17 APR 2019

NEWS FROM USA

NEW STRENGTH APPROVAL

Approval Date	Product Name	NDA Sponsor	Brand Name	Prescribing information
12 April 2019	Triamcinolone acetonide injectable suspension	Apothecon (BMS)	KENALOG-80	Link

 

505(B)2s IN PIPELINE:

Riluzole Oral film (Aquestive):

-   Aquestive Therapeutics Announces USFDA Acceptance of NDA for Riluzole Oral Film for treatment of ALS.

-   PDUFA goal date is Nov. 30, 2019.

-   Riluzole oral film received FDA orphan drug designation in January 2018.

Full Press release: Link

 

ANDA APPROVALS

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
10 Apr 2019	Testosterone 1.62% Gel	Actavis Labs	Androgel (Abbvie)	Two (Perrigo’s 180 days PC exclusivity expired on 10 Apr. 2019)
10 Apr 2019	Testosterone 1.62% Gel	Amneal
10 Apr 2019	Testosterone 1.62% Gel	Dr Reddys
10 Apr 2019	Naftifine Hydrochloride 2% gel	Taro	Naftin 2% gel (Sebela Ireland)	None
10 Apr 2019	Ambrisentan Tablets	Sigmapharm	Letairis (Gilead)	Five
10 Apr 2019	Ambrisentan Tablets	Par Pharm
10 Apr 2019	Esomeprazole Magnesium Capsules	Amneal Pharms	Nexium (Astrazeneca)	Eight
10 Apr 2019	Sodium Nitroprusside Injection	Dr Reddys	Nitropress	More Than 10
11 Apr 2019	Mifepristone Tablets	Genbiopro	Mifeprex (Danco)	None*
12 Apr 2019	Cyproheptadine Hydrochloride Tablets	Beximco Pharms	Periactin (Merck)	Ten
12 Apr 2019	Daunorubicin Hydrochloride Injection	Hisun Pharm	Daunorubicin Hydrochloride (West-Ward)	One (Teva)
12 Apr 2019	Bimatoprost 0.03% ophthalmic Solution	Alembic	Lumigan 0.03% (Allergan)	Five
15 Apr 2019	Doxycycline Hyclate Tablets	Apotex	Acticlate (Almirall)	Three
15 Apr 2019	Fluoxetine Hydrochloride Tablets	Lupin Ltd	Prozac (Lilly)	Seven

*Mifeprex was mentioned in FDA’s latest Off patent off exclusivity products without an approved generic list. Genbiopro’s generic product may receive CGT (Competitive Generic Therapy) exclusivity.

TENTATIVE ANDA APPROVALS

Approval Date	Drug	Company
10 Apr 2019	Lurasidone Hydrochloride	Emcure

 

USFDA INSPECTIONS:

Dr. Reddy’s Laboratories announced receipt of EIR for Formulation facility from USFDA

-      The facility (Formulation Manufacturing Plant Unit-3) is located in Hyderabad.

-      In February 2019, the same site has received Form 483 with 11 observations from USFDA.

Full Press release: Link

OTHER NEWS FROM THE USA

Eagle pharmaceuticals, Inc. expands licensing agreement for Bendeka™ with Teva pharmaceuticals international Gmbh

- Under the terms of the revised licensing agreement, beginning on October 1, 2019, Eagle’s royalty payment will increase from 25% to 30% of BENDEKA net U.S. sales.

-  The royalty rate will increase by one percentage point on each anniversary of October 1, 2019 until it reaches 32%, and it will remain at 32% thereafter.

-   The revised agreement also extends the U.S. BENDEKA royalty term until it is no longer sold in the United States. The previous U.S. royalty term was set to expire in 2025.

Full Press release: Link

 

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