Bringing Quality for Life13 November 2015
August 21, 2012


COLUMBUS, OH – August 3, 2012 – Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Applications (ANDA’s) for Montelukast Sodium Tablets, 10mg and Montelukast Sodium Chewable Tablets, 4mg and 5mg by the U.S. Food and Drug Administration. Both products are available in bottles of 30 and 90 tablets for immediate shipment to wholesalers and pharmacies nationwide.

Roxane Laboratories’ Montelukast Sodium Tablets and Montelukast Sodium Chewable Tablets are AB rated to SINGULAIR® (montelukast sodium) tablets and chewable tablets. Combined annual sales of SINGULAIR® are approximately $4.7 Billion1.

Full prescribing information for Montelukast Sodium Tablets and Montelukast Sodium Chewable Tablets is available on the Roxane Laboratories website at or upon request by calling Roxane Laboratories Technical Product Information at 1.800.962.8364.

About Roxane Laboratories, Inc.
Roxane Laboratories is located in Columbus, OH in a modern 500,000 square foot manufacturing and laboratory facility. The facility spans 70 acres and currently employs over 1,000 people. Currently, Roxane Laboratories markets over 80 medications in nearly 250 package sizes, focusing on an expanding line of Multisource pharmaceutical products including: bulk and unit-dose liquids and solids; coated, sustained-release and controlled-release tablets; nasal sprays, cytotoxics and CII narcotics.

Roxane Laboratories, Inc., is a subsidiary of Boehringer Ingelheim Corporation, based in Ridgefield, CT and a member of the Boehringer Ingelheim group of companies.

For more information, please visit

AboutBoehringer Ingelheim
Boehringer Ingelheim Corporation based in Ridgefield, CT, is the US headquarters to seven subsidiaries and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates in 50 countries and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

For more information, please visit

1IMS MAT dollar sales ending 3/2012

SINGULAIR® is a registered trademark of Merck & Co., Inc.

Media Contact

  • Keri Butler

    Public Affairs & Communications, Boehringer Ingelheim Roxane Inc. and Roxane Laboratories Inc.