USFDA approves Sun Pharma’s generic Amphotericin B Liposome for injection

INDIA – Sun Pharmaceuticals Industries announced that one of its wholly-owned subsidiaries received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Amphotericin B Liposome for Injection.

The generic product approval is based on the reference product AmBisome Liposome for Injection, 50 mg/vial.

Sun Pharma has been granted Competitive Generic Therapy (CGT) designation by the US FDA, and as the first approved generic, the product is eligible for 180 days of CGT exclusivity.

According to IQVIA Health data from October 2021, AmBisome Liposome for Injection, 50mg/vial had annualized sales of approximately US$136 million in the United States.

In other related news, in September, Zydus Cadila announced that its subsidiary had received preliminary approval from the US Food and Drug Administration for its new drug application for sitagliptin base 25, 50, and 100 mg tablets.

The medication is an anti-diabetic that is used to treat type 2 diabetes. The active moiety sitagliptin in Zydus’ sitagliptin base is in a different form than in the branded reference product, Januvia (sitagliptin phosphate).

The USFDA granted Cadila Healthcare 180 days of exclusivity and final approval to market nelarabine injection in the United States in November.

The company announced that it had received Competitive Generic Therapy (CGT) designation for a single-dose vial of Nelarabine Injection.

Cadila stated that it is the “first approved applicant” for nelarabine injection, and as such, it is eligible for 180 days of CGT exclusivity for nelarabine injection with this approval.

Nelarabine injection is a chemotherapy drug that is used to slow or stop the growth of cancer cells in certain types of leukemia and lymphoma. Nelarabine belongs to a class of drugs known as antimetabolites.

More FDA’s latest approvals

More FDA’s latest approvals

Still on FDA approvals front, Eagle Pharmaceuticals Inc has announced that the US Food and Drug Administration approved its generic version of Endo International’s blood pressure drug Vasostrict, sending its stock to a more than one-month high.

The FDA’s approval comes just months after a Delaware federal court ruled that Eagle’s proposed generic, vasopressin, did not infringe on Endo subsidiary Par Pharmaceutical’s patents.

Vasostrict generated more than US$786 million in sales last year, making it the Endo’s best-selling drug, as Reuters reports.

The FDA approved AbbVie’s Rinvoq for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or demonstrated intolerance to one or more tumor necrosis factor (TNF) blockers.

Rinvoq was approved for the first time in 2019 as a treatment for rheumatoid arthritis. It has also received regulatory approval for the treatment of adult patients with active psoriatic arthritis and active ankylosing spondylitis (AS) who have not responded adequately to conventional therapy.

Rinvoq’s latest approval comes just weeks after the FDA issued new safety warnings for JAK inhibitors. As previously reported, the FDA made its decision after reviewing a post-marketing study on Pfizer’s Xeljanz (tofacitinib), another JAK inhibitor.

According to the findings of that study, patients who received Xeljanz had a higher rate of major adverse cardiac events (MACE), malignancy, mortality, and thrombosis.

Following the review, the FDA issued a decree requiring JAK inhibitor warning labels to be updated to reflect the most recent safety concerns. This class of drugs already has boxed warnings for blood clots and lymphoma.

In addition to Rinvoq and Xeljanz, Eli Lilly’s Olumiant is an FDA-approved JAK inhibitor.

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