Breckenridge wins final FDA approval for launch of generic Tarceva
13 November 2019 -

Pharmaceutical company Breckenridge Pharmaceutical Inc reported on Tuesday the receipt of US Food and Drug Administration final approval for an Abbreviated New Drug Application for Erlotinib Hydrochloride Tablets (generic Tarceva) in EQ 25mg base, EQ 100mg base and EQ 150mg base strengths for the treatment of non-small cell lung cancer and pancreatic cancer.

The Abbreviated New Drug Application of Erlotinib Hydrochloride Tablets is reportedly held by Natco Pharma Limited and developed in collaboration with MEDIK Ltd.

Under Breckenridge's marketing, sale and distribution agreement, the Erlotinib Hydrochloride Tablets will be manufactured and supplied by Natco and Breckenridge plans to launch the product immediately.

According to industry sales data, Tarceva and its therapeutic equivalents generated annual sales of approximately USD145m in the year ended 30 September 2019.