From USFDA
Jubilant Life Sciences announced that it has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (US FDA) for -Mycophenolate Mofetil USP, 250 mg Capsules and 500 mg Tablets (from its US subsidiary, Jubilant Cadista Pharmaceuticals Inc.)
Rizatriptan Tablets 5 mg and 10 mg (from its Indian subsidiary, Jubilant Generics).
Mycophenolate Mofetil USP, 250 mg Capsules and 500 mg Tablets is the generic version of Cellcept (of Roche), an immunosuppressant which is used to help prevent organ rejection in transplants. The current annualized US market size for Mycophenolate Mofetil USP, 250 mg Capsules and 500 mg Tablets as per IMS is USD 245 Million.
Rizatriptan Tablets 5 mg and 10 mg is the generic version of Maxalt (of Merck), used for the treatment of migraine. The current annualized US market size for Rizatriptan Tablets 5 mg and 10 mg as per IMS is USD 70 Million.
Powered by Capital Market - Live News
