NEWS 24 APR 2019

NEWS FROM USA

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Solifenacin Succinate Tablets	Teva	VESIcare	$955 Million	Link

505(b)2 NDA APPROVALS

Approval Date	Product Name	NDA Sponsor	Brand Name	Prescribing information
16 Apr 2019	Cysteine Hydrochloride Injection	Exela Pharma	Elcys	Link

OTHER NDA APPROVALS

Approval Date	Product Name	NDA Sponsor	Brand Name	Prescribing information
22 Apr 2019	Ivabradine Solution	Amgen Inc	Corlanor	Link

ANDA APPROVALS

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
19 Apr 2019	Valrubicin Solution	Custopharm Inc	Valstar Preservative Free (Endo)	None
19 Apr 2019	Nateglinide Tablets	Cadila Pharms	Starlix  (Novartis)	Six
19 Apr 2019	Mesalamine Suppository	Pharm Sourcing	Canasa (Allergan)	One (Mylan)
19 Apr 2019	Fenofibrate Capsules	Ingenus	Tricor  (Abbvie)	Eight
19 Apr 2019	Amoxicillin; Clavulanate Potassium Suspension	Aurobindo	Augmentin 125 (Neopharma)	Three
19 Apr 2019	Teriflunomide Tablets	Alembic	Aubagio (Sanofi)	Four
19 Apr 2019	Everolimus Tablets for suspension	Mylan	Afinitor Disperz (Novartis)	None
19 Apr 2019	Tobramycin Solution	Alembic	Tobrex (Novartis)	Five
22 Apr 2019	Minoxidil Aerosol (For Men)	Taro	Men's Rogaine (Johnson And Johnson)	Two
22 Apr 2019	Minoxidil Aerosol (For Women)	Taro	Men's Rogaine (Johnson And Johnson)	Two
22 Apr. 2019	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate ER Capsules	Specgx	Adderall XR 5 (Shire)	Five

TENTATIVE ANDA APPROVALS

Approval Date	Drug	Company
18 Apr 2019	Fingolimod	Ezra Ventures
19 Apr 2019	Fingolimod	Accord Hlthcare
19 Apr 2019	Zoledronic Acid	Gland Pharma
23 Apr 2019	Rufinamide	West-Ward

TENTATIVE NDA APPROVALS

Approval Date	Drug	Company
18 Apr 2019	Budesonide ER Capsule	SUN PHARMA

USFDA INSPECTIONS:

U.S. FDA classifies the inspection of Lupin's Pithampur (Indore) Unit-2 facility as OAI.

-      The inspection was conducted by USFDA in January 2019.

-      As per the press release, the Company does not believe that this classification will have an impact on disruption of supplies or the existing revenues from operations of this facility.

-      Full Press release: Link

USFDA retains the OAI status of Indoco's Goa Plant I

-      This is the Finished dosages facility situated in Goa.

-      The inspection was conducted by USFDA in January 2019.

-      As per press release, the company believe that this OAI status will not impact their current commercial supplies to USA or revenues from this manufacturing facility

-      Full Press release: Link

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