Weekly summary: 16 Sep. - 20 Sep.2019

NEWS FROM USA

505(b)(2) APPROVALS

Approval Date	Product Name	NDA Sponsor	Comment
18 Sep 2019	Baclofen oral solution (Ozobax) 5 mg/5 ml	Metacel Pharma	Ozobax is the first oral solution formulation of Baclofen approved in the US. Currently Baclofen is available as oral tablets and injectable formulations in the US. Indications and dosing patterns of Ozobax are similar to that of tablets. Comparison between Baclofen oral solution and Baclofen tablets is available here. Prescribing Information| FDA Approval letter
19 Sep 2019	Potassium phosphates injections	CMP development LLC	It is a phosphorus replacement product indicated as a source of Phosphorus. Injectable solution supplied in glass vial. The solution is administered after dilution or admixing by the intravenous route. Prescribing Information| FDA Approval letter

 

OTHER NDA APPROVAL

Approval Date	Product Name	NDA Sponsor	Comment
20 Sep. 2019	Semaglutide oral tablets (Rybelsus)	Novo Nordisk	Rybelsus is the first oral glucagon-like peptide (GLP-1) receptor protein treatment approved for use in the United States. Injectable Semaglutide was approved by FDA in Dec. 2017. Previously approved other GLP-1 agonist Liraglutide is available only in the injectable form. FDA Press announcement | Prescribing Information

 

 

NEW GENERICS LAUNCHES IN US

LAUNCH DATE	DRUG	Marketer	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
17 Sep. 2019	Fulvestrant injections	Mylan	Faslodex (AstraZeneca)	$550 Mn	Link
16 Sep. 2019	Lansoprazole delayed release capsules 15 mg	Dr. Reddy’s Laboratories	Prevacid 24HR (Takeda)	$57 Mn	Link

 

NEW STRENGTH APPROVALS

Write us on pharmacaption@gmail.com, if you want to know new strengths approved in existing NDAs during August 2019.

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