Zydus Cadila gets FDA nod for chemotherapy drug Pemetrexed generic
Cadila Healthcare (also known as Zydus Cadila) said that it has secured tentative approval from the US Food and Drug Administration (FDA) for marketing Pemetrexed for Injection in 100mg/vial, 500mg/vial, and 1000mg/vial, single-dose vials.
Pemetrexed for Injection is the generic for Eli Lilly and Company (Lilly) owned Pemetrexed, which is sold under Alimta and other brand names.
Pemetrexed has FDA approvals for the treatment of certain types of cancers like lung cancer and mesothelioma. The chemotherapy drug functions by slowing or preventing the growth of cancer cells.
Zydus Cadila will manufacture Pemetrexed for Injection at its formulation manufacturing facility in Ahmedabad. The Indian pharma company now has 319 approvals and has to date filed more than 400 ANDAs since the start of the filing process in FY 2003-04.
Recently, Zydus Cadila announced obtaining a tentative approval from the FDA to market Brivaracetam Tablets for the treatment of epilepsy in the strengths of 10mg, 25mg, 50mg, 75mg, and 100mg.