Le Lézard
Classified in: Health
Subject: FDA

Breckenridge Announces Final Approval of its ANDA for Exemestane Tablets (Aromasin®)

BOCA RATON, Fla., Feb. 27, 2019 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Exemestane Tablets, 25mg, generic for Aromasin® Tablets by Pfizer.  Breckenridge's Exemestane Tablets product was developed in collaboration with Medikl Ltd. and MSN Laboratories Private Ltd.  MSN will manufacture and supply the product from its facilities in Hyderabad, India.  Additional announcements will be made prior to product launch. Exemestane Tablets generated annual sales of $65 million during the twelve months ending December 31, 2018, 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 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. The company has a multi-product agreement with Breckenridge for marketing its products in the U.S., with five additional products expected to be launched in the following two years.

About MSN:
MSN Group (MSN) is the fastest growing research-based pharmaceutical company out of India. Founded in 2003 with a mission to make health care affordable, MSN has nine API (including Oncology) and five finished dosage facilities, established across Hyderabad and in the U.S.  The group has an integrated R&D Center for both API and formulation under one roof, dedicated to research and development of pharmaceutical products to make them more accessible.  With a core focus on speed and consistency in delivery, MSN has won the trust of more than 350 customers across 65 countries around the globe, including the U.S., Europe, Latin America, Middle East, Asia-Pacific, Africa and CIS markets. MSN's product basket offers over 250 APIs and 120 formulations covering 35 major therapies.

SOURCE Breckenridge Pharmaceutical, Inc.

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News published on 27 february 2019 at 10:00 and distributed by: