Natco Pharma seeks USFDA nod for generic Erdafitinib Tablets

Hyderabad: NATCO Pharma Limited has announced the submission of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for the generic version of Erdafitinib Tablets 3 mg, 4 mg, and 5 mg strengths.

Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC). Erdafitinib Tablets are marketed in the United States (US) by Janssen Biotech under brand Balversa.
NATCO has been named as defendant in a lawsuit filed in the US district court of New Jersey by Janssen Pharmaceutica NV, Janssen Biotech Inc. and Otsuka holdings Co.’s Astex Therapeutics Ltd.
"NATCO believes that the ANDA is possibly sole first-to-file based on its filing date and may be eligible for 180 days of marketing exclusivity at the time of launch," the company stated.
Read also: Multiple Myeloma medicine: Natco Pharma unveils Pomalidomide under brand NAT-POMALIDOMIDE in Canada
Balversa has recorded sales of USD 36.5 million in the US market for the year ending December 2022, as per IQVIA database.
Balversa is a registered trademark of the Janssen group of companies.
Read also: Natco Pharma gets USFDA nod for Tipiracil Hydrochloride and Trifluridine Tablets

Natco Pharma Limited is a vertically integrated and R&D focused pharmaceutical company engaged in developing, manufacturing and marketing of finished dosage formulations (“FDF”) and active pharmaceutical ingredients (“APIs”). The company's focus is primarily on niche therapeutic areas and complex products. It markets and distributes products in over 40 countries. It sells FDF products in the United States, India, Europe and the rest of the world (“RoW”). Natco also operates in certain key geographies through its subsidiaries.

Natco Pharma is also engaged in contract manufacturing business, whereby it undertakes selected contracts with pharmaceutical companies to manufacture and supply pharmaceutical products.

Read also: Natco Pharma posts Rs 715.3 crore of Profit after tax for year ended March 31st, 2023



from Medical News, Health News Latest, Medical News Today - Medical Dialogues | https://ift.tt/DRFjkWh

Comments

Post a Comment

Popular posts from this blog

'Details sought include Third-party info, hence exempted under RTI Act': NMC on RTI query on Faculty Gap in Medical Colleges

Image
New Delhi:  Stating that the details sought under the RTI includes third-party information, the National Medical Commission (NMC) has refused to disclose the names of the medical colleges that fell short on faculty counts and other teaching infrastructure. Recently activist Dr. KV Babu filed an application under the Right to Information Act seeking the details of the notices issued by the NMC Undergraduate Medical Education Board (UGMEB) to the medical colleges for deficiencies in Clinical Material and staff during the period from 01/01/2023 to 30/04/2024. He also sought to know the details of the fine imposed or the action taken by the NMC UG Board from 01/01/2023 to 30/04/2024. In response, the Apex medical regulatory body in India has said that the concerned information includes third party information. "Since the information sought by you, includes third party information, hence the same is exempted for as per Section 8(1) (j) of the Right to Information Act, 2005," th...
Read more

Zasocitinib therapy highly efficacious for treatment of severe plaque psoriasis: JAMA

Image
A recent study published in the Journal of American Medical Association revealed that Zasocitinib could be a breakthrough in the treatment of moderate to severe plaque psoriasis. Psoriasis is a chronic inflammatory skin condition characterized by red, scaly patches, affects millions throughout the globe. While several treatments exist, the demand for new, effective, and well-tolerated oral therapies remains high. Zasocitinib, a highly selective allosteric tyrosine kinase 2 (TYK2) inhibitor, emerges as a promising candidate to meet this need. This trial was conducted between August 2021 and September 2022 across 55 centers in the US and Canada and found that Zasocitinib not only significantly improved skin clearance in patients but also expressed a favorable safety and tolerability profile. The study enrolled a total of 287 participants aged between 18 and 70 years, each with a Psoriasis Area and Severity Index (PASI) score of 12 or greater, a Physician’s Global Assessment score of 3...
Read more

New wearable laser device may monitor brain blood flow to gauge stroke risk, reports research

Image
Researchers have developed a laser-based device that can be placed on the head to non-invasively monitor changes in brain blood flow and volume. The new device could one day help save lives by offering a direct and simple way to assess stroke risk based on physiological markers rather than indirect markers like lifestyle factors. Strokes occur when blood flow to the brain is blocked or reduced, causing debilitating brain cell damage. With about 15 million people worldwide affected by strokes each year, it is the second leading cause of death and a leading cause of long-term disability. “The lack of a cost-effective and scalable stroke risk assessment system complicates long-term stroke prevention because a physician can’t tell whether a patient’s risk is stable or worsening,” said research team member Simon Mahler, a postdoctoral scholar in Changhuei Yang’s laboratory at the California Institute of Technology. “This new method could help catch early signs of increased stroke risk, w...
Read more