FDA Approval of Generic Drug Offers Hope for BPH Patients,

FDA Approval of Generic Drug Offers Hope for BPH Patients,

Unichem Laboratories has announced it has received final Abbreviated New Drug Application (ANDA) approval from the U.S. FDA for a drug for the treatment of benign prostatic hyperplasia (BPH) in adult patients.

Alfuzosin HCI Extended-Release tablets are Unichem’s first PARA IV (a Food and Drug Administration paragraph IV certification that grants a generic company a period of market exclusivity of 180 days) ANDA approval. According to a press release, Alfuzosin Hydrochloride Extended-Release 10 mg tablets are therapeutically equivalent to Concordia Pharmaceuticals’ UroXatral Extended-release 10 mg tablets.

As UroXatral’s generic, Alfuzosin HCI is also a selective antagonist of post-synaptic alpha1-adrenoreceptors, located in the bladder’s base and neck, prostatic capsule, and prostatic urethera. Alfuzosin HCI belongs to a class of drugs called alpha-blockers that block adreneroceptors, resulting in the relaxation of bladder and prostate muscles, lessening the symptoms of BPH and improving urine flow.

In previous study trials of UroXatral, patients were asked seven questions from the International Prostate Symptom Score (IPSS) to assess severity of their irritative and obstructive symptoms, such as urgency, frequency, weak stream, and incomplete emptying. Results showed a statistically significant reduction of symptom severity compared to a placebo in all studies, and also in peak urinary flow rate. Reported side effects included impotence, pain, fatigue, headache, and upper respiratory tract infection.

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A high score — above 10 mm — in intravesical prostatic protrusion is predictive of adverse clinical outcomes in patients with urinary problems due to benign prostatic hyperplasia (BPH), according to a study titled “Intravesical Prostatic Protrusion as a Predicting Factor for the Adverse Clinical Outcome in Patients with Symptomatic Benign Prostatic Enlargement Treated with Dutasteride” and published in the journal Urology.


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