NEWS 21 APRIL 2019

NEWS FROM USA

505(b)2 NDA APPROVALS

 

Approval Date	Product Name	NDA Sponsor	Brand Name	Prescribing information
15 Apr. 2019	Tranexamic Acid In Sodium Chloride Injection (10 mg/ml)	Exela Pharma	Tranexamic Acid In Sodium Chloride Injection	Link

 

-      Currently marketed Tranexamic acid (100 mg/ml) is supplied in single dose vials. While Exela’s product (10 mg/ml) is supplied in polymeric bags sealed with a Twist Off port and oversealed in an aluminum pouch.

 

ANDA APPROVALS

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
15 Apr 2019	Acetazolamide Injection (500mg base/vial)	Zydus Pharms	Diamox (Teva)	Five
15 Apr 2019	Clobazam suspension	Taro Pharm	Onfi (Lundbeck)	Six
16 Apr 2019	Buspirone tablets	Epic pharma	Buspar (BMS)	More than 10
16 Apr 2019	Nifedipine XR tablets	SPIL	Procardia Xl (Pfizer)	Six
16 Apr 2019	Hydroxyprogesterone Caproate 1250 mg/5 ml	Eugia	Makena (Amag)	Slayback, Sun
16 Apr 2019	Hydroxyprogesterone caproate 250 mg/ml	Eugia	Makena (Amag)	Luitpold, Slayback
16 Apr 2019	Acetaminophen XR tablets	Granules india	Tylenol (J & J)	Four
17 Apr 2019	Loteprednol etabonate ophthalmic suspension*	Hi tech	Lotemax (Bausch & Laumb)	None
17 Apr 2019	Fluticasone propionate nasal spray	Hi tech	Flonase allergy relief (GSK)	Two
17 Apr 2019	Azithromycin tablets	Cspc ouyi	Zithromax (Pfizer)	Eight
17 Apr 2019	Amphetamine sulfate tablets#	Aurolife pharma	Evekeo (Arbor)	Amneal
18 Apr. 2019	Busulfan injections 60 mg/10ml	Shilpa Medicare	Busulfex (Otsuka)	Eight
19 Apr. 2019	Naloxone nasal spray	Teva	Narcan (Adapt)	None

*Lotemax was mentioned in FDA’s latest off-patent off-exclusivity products without an approved generic list. 

#Previously Amneal’s Evekeo generic has received CGT exclusivity

TENTATIVE ANDA APPROVALS

Approval Date	Drug	Company
17 Apr 2019	Minocycline XR tablets 55 mg^	Mylan

^Mylan may receive final approval for this product on expiration of Lupin’s PC exclusivity on 21 Aug. 2019.

 

USFDA INSPECTIONS:

Shilpa Medicare’s Pharmaceutical Reasearch & Development unit received EIR from USFDA with intimation of closure of inspection on 08 Apr 2019.

-      The facility is located in Modavalasa, Vizianagaram (Dt), Andhra Pradesh.

-      Earlier, this R&D site has undergone an inspection by the USFDA during 11 Feb 2019 to 13 Feb 2019, wherein they were issued a Form 483 with 1 (one) observation.

-      Full Press release: Link

 

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