Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Mylan Pharmaceuticals, a subsidiary of Mylan, has received final approval from FDA for its abbreviated new drug application (ANDA) for Tamsulosin Hydrochloride capsules USP, 0.4mg, the generic version of Boehringer Ingelheim's benign prostatic hyperplasia (BPH) treatment, Flomax.
Subscribe to our email newsletter
Flomax is used to treat the symptoms of an enlarged prostate. Flomax doesn’t shrink the prostate. Instead, it relaxes the muscle around it, freeing the flow of urine and decreasing urinary symptoms.
Flomax belongs to a group of drugs called alpha-adrenergic (AL-fa ad-ren-ER-jik) blockers. Flomax relaxes veins and arteries so that blood can more easily pass through them. It also relaxes the muscles in the prostate and bladder neck, making it easier to urinate.
Tamsulosin was developed by Yamanouchi Pharmaceuticals (now part of Astellas Pharma) and is marketed by various companies under licence, including Boehringer-Ingelheim and CSL.
Tamsulosin hydrochloride extended-release capsules are marketed under the trade names Flomax, Flomaxtra and Urimax, though generic non-modified release capsules are still approved and marketed in many countries, such as Canada. The US patent for Flomax expired October 2009.
Currently, Mylan has 139 ANDAs pending FDA approval. Thirty-seven of these pending ANDAs are potential first-to-file opportunities.