Weekly summary September 23 - 27, 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
17 Sep. 2019	Daptomycin injections	Cipla	Cubicin (Cubist)	$606 Mn	Link

 

NEW PARAGRAPH IV FILING

Drug	Strengths	Corresponding RLD	Date of Submission	Type of Submission (Based on Date)	Number Of ANDAs submitted
Sacubitril and Valsartan tablets	24 mg/26 mg, 49 mg/51 mg 97 mg/103 mg	Entresto (Novartis)	8 July 2019	NCE-1	20
Dolutegravir Sodium and Lamivudine tablets#	50 mg/300 mg	Dovato (ViiV)	30 July 2019	Open first to file	1
Cabozantinib tablets	20 mg, 40 mg and 60 mg	Cabometyx (Exeltis)	16 Aug. 2019	Open first to file	1
Levothyroxine Sodium capsules	88 mcg, 100 mcg and 125 mcg	Tirosint (IBSA)	1 Aug. 2019	Open first to file	1
Epinephrine injection	30 mg/30 ml	Adrenalin (Par)	20 Aug. 2018	Open first to file	1
Brexpiprazole tablets	0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg	Rexulti (Otsuka)	10 July 2019	NCE-1

FDA’s updated list on Paragraph four filings is available here.

Dolutegravir/Lamivudine combination tablet was approved by FDA in April 2019.

505(b)(2) IN PIPELINE

Rizatriptan orally disintegrating film (IntelGenX): IntelGenx announces resubmission of Rizaport^® 505(b)(2) NDA.

-      Back in April 2019, the Company announced that it had received a Complete Response Letter (“CRL”) from the FDA regarding the NDA for RIZAPORT^® VersaFilm^® accepted by the Agency on November 20, 2018.

-      The issues cited in the April CRL relate to the Chemistry, Manufacturing and Controls section of the application. The FDA requested additional information, but no new bioequivalence study.

-      The resubmitted NDA is subject to the FDA’s acceptance review, the results of which are expected within 30 days.

-      Press release: Link