Aurobindo Pharma arm gets U.S. FDA nod for generic of BMS' cancer drug
Bioequivalent and therapeutically equivalent to the reference listed drug Sprycel Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol-Myers Squibb Company (BMS), the product is expected to be launched by June. The approved product has an estimated market size of $1.8 billion for the twelve months ending February 2025, Aurobindo said, citing IQVIA MAT numbers.
Dasatinib Tablets is indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia in chronic phase; adults with chronic, accelerated or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy; and adults with Ph+ acute lymphoblastic leukaemia with resistance or intolerance to prior therapy, the company said.
This is the 181st ANDA approval, including nine tentative approvals received, out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oncology oral and sterile specialty products.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
The Hindu
4 days ago
- The Hindu
Natco Pharma's Hyderabad API plant receives EIR from U.S. FDA
Generic drugmaker Natco Pharma has received an establishment inspection report from the U.S. Food and Drug Administration for its active pharmaceutical ingredient manufacturing facility in Hyderabad. The U.S. FDA had inspected the API facility, in Mekaguda here, from June 9-13 and issued Form 483 with one observation. The regulator had classified it as 'voluntary action indicated' (VAI), the company said on Thursday, announcing issue of the EIR. Natco Pharma shares closed 3.58% lower at ₹997.70 each on the BSE.
The Hindu
4 days ago
- The Hindu
Lupin gets U.S. FDA nod for two generic diabetes drugs
Generic drugmaker Lupin has received U.S. Food and Drug Administration approval for its abbreviated new drug applications for Liraglutide Injection single-patient-use prefilled pens and Glucagon for injection vials. Both the products will be manufactured at the company's injectable facility in Nagpur, Lupin said. Liraglutide injection 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pen is bioequivalent to Novo Nordisk's Victoza injection and had an estimated annual sale of $458 million in the U.S, the company said citing IQVIA MAT May numbers. The drug is indicated to improve glycaemic control in adults and children, aged above 10 years, with type 2 diabetes mellitus. Glucagon for Injection USP, 1 mg/vial, is bioequivalent to Eli Lilly and Company's Glucagon for Injection, 1 mg/vial. It is indicated for treatment of severe hypoglycaemia in paediatric and adult patients with diabetes mellitus and as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. It had an estimated annual sale of $124 million in the U.S. Chief Scientific Officer Shahin Fesharaki said the two products are a meaningful enhancement to the company's portfolio.
Business Standard
4 days ago
- Business Standard
Natco Pharma receives USFDA EIR for Hyderabad API facility
Natco Pharma informed that the U.S. Food and Drug Administration (US FDA) has issued an EIR for its active pharmaceutical ingredient (API) division located in Mekaguda, Hyderabad, Telangana. The US FDA had conducted an inspection at the companys aforementioned unit from 9 June to 13 June 2025. Post the inspection, the company received one observation in Form-483, which was classified as voluntary action indicated (VAI). In a regulatory filing made during market hours today, Natco Pharma announced that it has received an establishment inspection report (EIR) for its API facility located in Mekaguda. NATCO Pharma, headquartered at Hyderabad, India, develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients and crop protection products. The companys consolidated net profit increased 5.3% to Rs 406.60 crore on a 14.3% jump in revenue from operations to Rs 1,221 crore in Q4 FY25 over Q4 FY24. Shares of Natco Pharma slipped 3% to Rs 1,003.75 on the BSE.
