Monthly summary August 2019

505(B)2 APPROVALS

Approval Date	Product Name	NDA Sponsor	Comment
20 Aug. 2019	Fulvestrant IM injections	Teva	This is second 505(b)2 for fulvestrant injections. Previously Fresenius has also received 505(b)2 approval for Fulvestrant.   Comparison between Faslodex, Fresenius’s 505(b)2 and Teva’s 505 (b)2 is available here.   Prescribing Information| FDA Approval letter
29 Aug. 2019	Metformin ER powder for oral suspension (Riomet ER)	Sun pharma	Riomet ER is the first extended release oral suspension of Metformin.   Currently Metformin is available in oral solution dosage form (Riomet).   More information - available here.   Prescribing Information| FDA Approval letter

 

 

FIRST TIME ANDA APPROVALS OF OFF-PATENT OFF-EXCLUSIVITY PRODUCTS*

 

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD
12 Aug. 2019	Halcinonide 0.1% topical cream#	Mylan	Halog (Sun)
19 Aug. 2019	Triamterene oral capsules#	Agnitio	Dyrenium (Concordia)
23 Aug.  2019	Aminocaproic acid oral syrup#	Amneal	Amicar (Clover)
26 Aug. 2019	Nitisinone oral capsules#	Novitium	Orfadin (Swedish orphan)
21 Aug. 2019	Posaconazole delayed release tablets*	Sinotherapeutics	Noxafil (Merck)

^#These products might have received CGT (Competitive Generic Therapy) designation.

*The only currently listed patent of Posaconazole delayed release tablets was expired in July 2019.

 Lannett has also entered into distribution agreement with Sinotherapeutics for Posaconazole delayed release tablets (See here). Lannett is going to launch this product in the near future (Brand sales $325 Mn, as quoted in the press release).