NEWS 5 JUNE 2019

NEWS FROM USA

NEW GENERICS LAUNCHES IN US

LAUNCH DATE	DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
4 June 2019	Sildenafil oral suspension*	Novitium	Revatio (Pfizer)	$200 Million	Link
3 June 2019	Isotretinoin capsules (re-launch)	Dr. Reddy’s laboratories	Accutane (Roche)	$525 Million	Link

 

*Sildenafil oral suspension (Novitium):

-      It is CGT designated product.

-    Innovator’s product is currently under shortage (See here). Hence, Novitium will be the lone player for Sildenafil oral suspension until Pfizer resumes the supply.

-    Previously Novitium has also received CGT exclusivity for Thiothixene capsules and Pyridostigmine syrup.

-    With this approval, Novitium becomes the first company to have 3 approved ANDAs with CGT exclusivity.

 

ANDA APPROVALS

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
3 June 2019	Leflunomide oral tablets	Abhai LLC	Arava (Sanofi)	Six
3 June 2019	Bromfenac sodium ophthalmic drops	Innopharma	N/A	Nine
3 June 2019	Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate	Cipla	Atripla (Gilead)	Two (Teva, Aurobindo)
31 May 2019	Felbamate oral suspension	Vistapharm	Felbatol (Mylan)	Two (Amneal, Taro)
31 May 2019	Amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	Par	Adderall XR (Shire)	Eight
31 May 2019	Atovaquone oral suspension	Abhai LLC	Mepron (GSK)	Six

 

OTHER NEWS FROM USA

Bosentan Tablet for oral suspension (Natco): Natco announces ANDA submission for Bosentan tablets for oral suspension.

-      Based on the filing date, Natco believes that they are the sole first filer for this product.

-      Bosentan tablets for oral suspension is indicated for paediatric patients.

-      Full Press Release: Link

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