Breckenridge gets FDA green light for generic Tarceva

Breckenridge has received the Food and Drug Administration’s clearance for erlotinib hydrochloride tablets.

The product is the generic of Natco Pharma’s Tarceva.  It was developed in collaboration with Medikl. 

The product will be manufactured and supplied by Natco to Breckenridge for Breckenridge's marketing, sale and distribution. 

Breckenridge's erlotinib hydrochloride tablets will be manufactured in 25 mg, 100 mg and 150 mg dosage strengths. Breckenridge plans to launch the product immediately.

Tarceva and its generics had a market value of approximately $145 million during the year ended Sept, 30, 2019, according to industry sales data.