Breckenridge Pharmaceutical announced the U.S. Food and Drug Administration (FDA) has granted final approval for an Abbreviated New Drug Application (ANDA) for Erlotinib Hydrochloride Tablets, generic for Tarceva®. The Abbreviated New Drug Application is held by Natco Pharma Limited and the product was developed in collaboration with MEDIKL Ltd. 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 EQ 25mg base, EQ 100mg base and EQ 150mg base strengths. Breckenridge plans to launch the product immediately.
Tarceva® and its therapeutic equivalents generated annual sales of approximately $145 million during the year ended September 30, 2019, according to industry sales data.
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