Final Approval of ANDA for Erlotinib Hydrochloride Tablets

[ November 12, 2019 ]

Berlin, CT  November 12, 2019– Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for an Abbreviated New Drug Application 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 Hyrdochloride 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.

About Breckenridge:

Breckenridge Pharmaceutical, Inc. is a privately held own-label distributor that performs pharmaceutical marketing, research and development, as well as marketing and distribution in the U.S. The company was founded in 1983 and markets a broad range of generic prescription products in many therapeutic categories. The Breckenridge label is recognized by wholesalers, distributors, chains, and managed care accounts, as well as retail pharmacies nationwide. The company markets over 70 products in a variety of dosage forms, including:tablets, capsules, liquids, suspensions, ophthalmics, nasal sprays, powders and injectable products.


About Natco:

Natco Pharma Limited is global generic pharmaceutical research, development manufacturing and marketing company. The company was established in 1981 in India. Natco supplies pharmaceutical products to over 50 countries across the globe including the United States. Natco specializes in the development and manufacturing of oncology and other specialty pharmaceuticals.


About Medikl:

MEDIKL is a privately held pharmaceutical company founded in 2009. MEDIKL is committed to the development of a premium range of generic pharmaceutical products in a variety of dosage forms, including:tablets, capsules, liquids and injectable products.



Tarceva®  is a registered trademark of Genentech USA, Inc.