Alembic Pharma Gets USFDA Approval for Generic Cancer Drug
By Rediff Money Desk, New Delhi Aug 02, 2024 13:18
Alembic Pharmaceuticals receives USFDA approval to market generic Nelarabine Injection for cancer treatment, expanding its portfolio to 211 ANDA approvals.
![Alembic Pharma Gets USFDA Approval for Generic Cancer Drug](https://im.rediff.com/money/2012/oct/28drug.jpg)
New Delhi, Aug 2 (PTI) Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator to market a generic drug for cancer treatment.
The company has received final approval from the US Food and Drug Administration (USFDA) for Nelarabine Injection (250 mg/50 mL) (5 mg/mL) single-dose vial, Alembic Pharmaceuticals said in a regulatory filing.
The approved company's product is therapeutically equivalent to Sandoz Inc's reference listed drug Arranon Injection, it added.
Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
According to IQVIA, Nelarabine Injection, 250 mg/50 mL has an estimated market size of USD 23 million for twelve months ending March 2024.
Alembic said it now has a cumulative total of 211 abbreviated new drug application (ANDA) approvals from the USFDA.
Shares of the company were trading 0.53 per cent up at Rs 1,222 apiece on the BSE.
The company has received final approval from the US Food and Drug Administration (USFDA) for Nelarabine Injection (250 mg/50 mL) (5 mg/mL) single-dose vial, Alembic Pharmaceuticals said in a regulatory filing.
The approved company's product is therapeutically equivalent to Sandoz Inc's reference listed drug Arranon Injection, it added.
Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
According to IQVIA, Nelarabine Injection, 250 mg/50 mL has an estimated market size of USD 23 million for twelve months ending March 2024.
Alembic said it now has a cumulative total of 211 abbreviated new drug application (ANDA) approvals from the USFDA.
Shares of the company were trading 0.53 per cent up at Rs 1,222 apiece on the BSE.
Source: PTI
DISCLAIMER - This article is from a syndicated feed. The original source is responsible for accuracy, views & content ownership. Views expressed may not reflect those of rediff.com India Limited.
You May Like To Read
TODAY'S MOST TRADED COMPANIES
- Company Name
- Price
- Volume
- GTL Infrastructure
- 2.74 (+ 2.62)
- 84886833
- Srestha Finvest
- 2.24 (+ 4.67)
- 34707853
- Ola Electric Mobilit
- 132.76 (+ 19.99)
- 27685743
- Suzlon Energy Ltd.
- 79.93 (+ 4.10)
- 27308498
- IFL Enterprises
- 1.22 (+ 4.27)
- 24757806
MORE NEWS
![Sebi Eases...](https://im.rediff.com/80-80/money/2024/aug/10sebi1.jpg)
Sebi Eases Compliance for Listed NCDs - New...
Sebi proposes amendments to simplify compliance requirements for entities with listed...
![Chandrasekaran:...](https://im.rediff.com/80-80/news/2018/jan/04modi.jpg)
Chandrasekaran: Learn From Indian Wisdom &...
Tata Group Chairman N Chandrasekaran emphasizes the importance of learning from Indian...
JSW Cement Files IPO Papers to Raise Rs 4,000...
JSW Cement has filed draft papers with Sebi for an IPO to raise Rs 4,000 crore. The IPO...