Natco Pharma and Alvogen Pine Brook LLC, USA, have submitted Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the US Food and Drug Administration (USFDA) for generic version of Ibrutinib Tablets of 140mg, 280mg, 420mg and 560mg strength (proposed generic equivalents to Imbruvica Tablets).
ANDA may be eligible for 180 days of marketing exclusivity at the time of potential launch of the product under certain circumstances.
Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.
