, June 9, 2014
/PRNewswire/ -- Acella Pharmaceuticals, LLC, a specialty pharmaceutical company, announces the approval of an Abbreviated New Drug Application (ANDA)1
for Tranexamic Acid Injection 1000 mg/10mL (100 mg/mL). The Food and Drug Administration (FDA) determined that Acella's ANDA is bioequivalent therefore, therapeutically equivalent to the reference listed drug, CYKLOKAPRON® - Tranexamic Acid Injection Solution
(Pharmacia & Upjohn, Inc.).
Tranexamic Acid Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
Tranexamic Acid Injection will be manufactured by Bioindustria L.I.M. S.p.A. in Italy.
"The approval of Tranexamic Acid Injection continues to demonstrate our strategy to work with global partners to gain approvals of ANDA, NDAs, and 510Ks," stated Allen Fields, Vice President, Head of Research and Development for Acella Pharmaceuticals.
"Developing and nurturing business and scientific partnerships that drive new product introductions is critical to our success at Acella. We are pleased to support our prescribers and patients with therapeutically relevant and important products that offer a strong standard of excellent quality," added Art Deas, Chief Operating Officer for Acella Pharmaceuticals.
About Acella Pharmaceuticals, LLC
Acella develops markets, sells and distributes a broad portfolio of non-branded pharmaceutical and other products in the areas of Dermatology, Women's Health, Pediatrics and other applications. Acella specializes in identifying and bringing to market quality, affordable products to customers and patients. For additional information please contact Acella at 678-325-5189.
1 An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.
A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
SOURCE Acella Pharmaceuticals, LLC