NEWS 10 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
09 July 2019	Guaifenesin and Pseudoephedrine ER tablets (OTC)	Dr. Reddy’s laboratories (DRL)	Mucinex D (RB health)	$71 Million	Link
09 July 2019	Imatinib mesylate tablets	Lupin	Gleevec (Novartis)	$548 Million	Link

 

NEW 505(b)2 LAUNCHES:

LAUNCH DATE	DRUG	Marketer	Brand name	RLD referred in NDA application	Press Release
09 July 2019	Epinephrine pre-filled syringes	Sandoz	Symjepi	Epipen (Mylan)	Link
09 July 2019	Levothyroxine sodium injectable solution*	Fresenius Kabi	N/A	Levothyroxine sodium lyophilized powder	Link

 

*Comparison between Fresenius’ newly approved solution and previously approved lyophilized product is available here (News 14 April 2019).

505 (b) 2 Approval

Approval Date	Product Name	NDA Sponsor	Brand Name	Prescribing information
08 July 2019	Amlodipine benzoate oral suspension	Silvergate Pharma	Katerzia	Link

KEY INFORMATION ON KATERZIA™

-      Katerzia™ is the first and only approved Amlodipine oral suspension in the US.

-      Indication: for the treatment of hypertension (high blood pressure) in adults and pediatric patients 6 years of age and older and coronary artery disease in adults

-      Strength: 1 mg/ml (total volume 150 ml).

-      Packaging: HDPE bottle with child resistant cap and tamper-evident seal.

-      Storage: refrigerated condition (2°C to 8°C/36°F to 46°F).

-      Excipients: citric acid, colloidal silicon dioxide, hypromellose, maltodextrin, polysorbate 80, simethicone, sodium benzoate, sodium besylate, sodium citrate, sodium hydroxide, sucralose, and water.

-      Patent application by innovator: US 201890098978

-      Full Press release: Link

ANDA APPROVALS

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
03 July 2019	Trientine Hydrochloride Capsules	Dr Reddys	Syprine (Aton)	Five
05 July 2019	Choline Fenofibrate  DR Capsules	Twi Pharms	Trilipix (Abbvie)	Five
05 July 2019	Ranolazine ER Tablets	Glenmark	RANEXA (GILEAD)	Six
05 July 2019	Fluoxetine Hydrochloride Tablets	G And W Labs	Fluoxetine Hydrochloride (Alvogen)	Seven
08 July 2019	Venlafaxine ER capsules	Annora pharma	Effexor XR (Wyeth)	More than 10

 

OTHER NEWS FROM US

 

  Lannett’s distribution agreement with Cediprof for Levothyroxine sodium tablets

-         Lannett has entered into a future exclusive supply and distribution agreement for the approved Levothyroxine Sodium Tablets USP of Cediprof, Inc.

-        Under the agreement, Lannett will commence U.S. distribution of the product no later than August 1, 2022.  Lannett will make an upfront payment of $20 million within the next five business days and will receive a portion of the net profits once it commences distribution of the product.

-        Full Press release: Link 

 

Manufacturing Concerns Lead FDA to Pull 31 Apotex ANDAs

-      FDA said that it is withdrawing the approval of 31 abbreviated new drug applications (ANDAs) held by Apotex after manufacturing deficiencies were found at two of the company’s plants.

-      The two facilities involved, according to FDA, were India-based Apotex Research Private Ltd. and Apotex Pharmachem India Private Ltd.

-      Full Article: Link

-      Federal register link is available here.

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