Lung cancer drug: Natco Pharma submits ANDA for generic version of Novartis Tabrecta
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-08-30 05:34 GMT | Update On 2024-08-30 05:34 GMT
Advertisement
Hyderabad: Natco Pharma Limited has announced its submission of an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for the generic version of TABRECTA (Capmatinib hydrochloride) Eq 150mg base and Eq 200 mg base tablets.
TABRECTA is the brand of Novartis.
Natco believes it is the first company to have filed a substantially-complete ANDA containing a paragraph IV certification for this product and expects to be eligible for 180 days of sole marketing exclusivity at the time of potential launch of the product under certain circumstances.
TABRECTA has recorded sales of USD 126 million in the US market for the year 2023.
Capmatinib hydrochloride is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a specific type of mutation.
Read also: Natco Pharma net profit increases 59 percent to Rs 668 crore in Q1
Natco Pharma Limited was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. With a modest beginning of operations as a single unit with 20 employees, Natco today has eight manufacturing facilities spread across India with modern research laboratories, capabilities in New Drug Development, etc.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.