Jubilant receives USFDA nod for immunosuppressant & migraine drugs

Jubilant Life Sciences Ltd has received abbreviated new drug application (ANDA) final approval from the US Food and Drug Administration (US FDA) for mycophenolate mofetil (an immunosuppressant drug) and rizatriptan, which is used for treating migraine.
 
Jubilant Cadista Pharmaceuticals Inc, the company’s US subsidiary, has received the approval for mycophenolate mofetil USP, 250 mg capsules and 500 mg tablets, while Jubilant Generics Ltd was granted approval for rizatriptan tablets 5 mg and 10 mg.
 
Mycophenolate mofetil tablet is the generic version of Cellcept (of Roche), an immunosuppressant which is used to help prevent organ rejection in transplants. As per IMS, the current annualised US market size for mycophenolate mofetil USP, 250 mg capsules and 500 mg tablets is $ 245 million.
 
Rizatriptan tablet is the generic version of Maxalt (of Merck), used for the treatment of migraine. The current annualised US market size for rizatriptan tablets 5 mg and 10 mg is $70 million, according to IMS.
 
As on September 30, 2014, Jubilant Life Sciences had a total of 781 filings for formulations of which 322 have been approved in various regions globally. This includes 72 ANDAs filed in the US and 46 dossier filings in Europe.