Alembic gets USFDA Final nod for Lurasidone HCL Tablets

Alembic has a cumulative total of 144 ANDA approvals (126 final approvals and 18 tentative approvals) from USFDA.

72
Medicine Tablets
Picture: Unsolash

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg, of Sunovion Pharmaceuticals Inc. (Sunovion).

Lurasidone Hydrochloride Tablets are indicated for monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression).


Also read:

Alembic gets USFDA nod for depression treatment drug

Caplin gets USFDA nod for Neostigmine Methylsulfate Injection

Gilead gets USFDA nod to treat metastatic urothelial cancer

NATCO gets tentative USFDA nod for Ibrutinib tablets

First AI device to help detect colon cancer gets USFDA nod

Aleor gets tentative USFDA nod for drug for topical treatment


Lurasidone Hydrochloride Tablets are also indicated for adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder.

Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg have an estimated market size of US$ 3.7 billion for twelve months ending December 2020 according to IQVIA. Alembic has settled the case with Sunovion and will launch its generic as per the terms of settlement.

Alembic has a cumulative total of 144 ANDA approvals (126 final approvals and 18 tentative approvals) from USFDA.

Subscribe for daily free updates on Telegram

Follow us on Facebook and Linkedin

For daily free updates on WhatsApp, click here

Enter your email address:

Delivered by FeedBurner