Pharmaceutical marketing, research and development company Breckenridge Pharmaceutical, Inc. announced it has received tentative Abbreviated New Drug Application (ANDA) approval of its generic Dutasteride Soft Gelatin Capsules 0.5mg product. Dutasteride is a triple 5a-reductase inhibitor that inhibits conversion of testosterone to dihydrotestosterone and is is indicated for treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. It is AB rated to Avodart, a drug marketed by GlaxoSmith Kline (GSK).
AB-rated drugs are generic products that meet necessary bioequivalence standards established by the U.S. Food and Drug Administration (FDA). A pharmaceutical company seeking to market a generic version of a branded drug may file a ANDA with the FDA, which then checks to determine whether or not the generic version submitted by the applicant company meets the necessary bioequivalence standards. Upon approval, the FDA will rate this generic version as an AB-rated generic drug that contains the same active pharmaceutical ingredient as the branded drug and is considered bioequivalent to a brand-name drug if it and if there is no significant difference in the formulation, quality, and effectiveness of the two drugs. Avodart annual sales totaled $467 million based on IMS Health sales data.
If a generic drug product application is submitted for approval before the expiration of any patents or exclusivities granted to the original, brand-name product, the FDA issues a tentative approval letter to the applicant. The tentative approval letter delays final approval of the generic drug product until all patent or exclusivity issues have been resolved. A product that has tentative approval cannot be marketed or sold in the United States, but enables generics access to poor nations under a US initiative permitting sale of generics to treat conditions where there is a significant public health impact, even though the originator drugs are still under patent protection. Breckenridge intends to launch its full AB approval ANDA with the FDA on November 20, 2015, upon the expiration of U.S. patent 5,565,467.
Prospective Dutasteride/AVODART users and their clinicians should be aware of FDA cautions that thorough assessment of patients prior to treatment with AVODART to rule out other urological diseases including prostate cancer. and that AVODART may be associated with an increase in high grade prostate cancer risk, and that its use increases risk of erectile dysfunction and decreased sexual desire.
Breckenridge Pharmaceutical, Inc. is a privately-held firm founded in 1983 that markets a broad range of generic prescription products in many therapeutic categories. The company markets more than 70 products worldwide in a variety of dosage forms including tablets, capsules, soft gel capsules, liquids, suspensions, ophthalmics, nasal sprays and powders.Breckenridge, has 30 approved ANDAs and 42 ANDAs that have been filed and are pending for approval from the FDA.
For more information, visit: http://www.bpirx.com.
Breckenridge Pharmaceutical, Inc.
Food and Drug Administration (FDA)
Generics and Biosimilars Initiative (GaBI)