Drugmaker Natco Pharma's marketing partner, Breckenridge Pharmaceutical (BPI), has received final approval from the US Food and Drug Administration for its new drug application for the avrolimus tablet.
The product is a generic version of Afinitor and is indicated in the treatment of breast cancer and some other types of cancer. BPI plans to launch 2.5 mg, 5 mg and 7.5 mg strength in the product within the next few weeks.
The 10 mg strength projection is subject to confidentiality terms of the agreement and license agreement with the owner of the Affinitor brand. The launch date will be announced later, Natco Pharma said on Monday. A release from the company, citing industry sales data, stated that Afinitor and its medical counterparts generated annual sales of $ 712 million in the US during 2020.
BPI, a subsidiary of Japan's Tova Pharmaceutical, collaborates with manufacturers globally for cost-effective generic medicines for US patients.
Ms of generics for safris
On Sunday, another pharmaceutical manufacturer from the Hyderabad MSN group, which also has a marketing partnership with BPI, announced to receive final approval for its Enda for Asenapine Sublingual Tablets in the strength of 5 mg from USADADA.
The approved product is a generic for Saffrice and is indicated for the treatment of schizophrenia and bipolar disorder.
MSN had previously received final approval for 2.5 mg and 10 mg strength of the same product. The product will be launched by BPI. According to industry sales data, Asenapine had annual sales of $ 239 million during the twelve months ended September 2020, MSN said in a release.