Aurobindo’s finasteride for prostate disease gets Switzerland approval

Aurobindo Pharma has received approval for its generic version of finasteride from Swiss regulator Swissmedic. Finasteride is used alone or in combination with another medication to treat enlargement of the prostate gland.

This is the first approval for Aurobindo Pharma, one of the largest API manufacturers in Asia, from Swissmedic, Government of Switzerland.

Swissmedic gave Aurobindo the license to sell finasteride APL tablets 5mg.

The drug is generic equivalent of Merck & Co., Inc’s Proscar Tablet.

Finasteride APL tablet is used to treat symptoms of enlargement of the prostate gland such as frequent and difficult urination.

Finasteride is available in brand names as Proscar, Propecia, Fincar, Finpecia, Finax, Finast, Finara, Finalo, Prosteride, Gefina, Appecia, Finasterid IVAX, Finasterid Alternova.

Finasteride is a synthetic antiandrogen which acts by inhibiting type II 5-alpha reductase, the enzyme that converts testosterone to dihydrotestosterone (DHT). It is used as a treatment in benign prostatic hyperplasia (BPH) in low doses, and prostate cancer in higher doses.

A study conducted in 2008 indicates that finasteride reduces the rate of prostate cancer by 30%. It is also indicated for use in combination with doxazosin therapy to reduce the risk for symptomatic progression of BPH.

Finasteride may also decrease the chance of needing surgery to cure prostate disease, studies suggest.  

Finasteride was approved initially in 1992 as Proscar, a treatment for prostate enlargement.

Though Merck’s patent on finasteride (for the treatment of BPH) expired on June 19, 2006, the US company secured a separate patent for the use of finasteride to treat male pattern baldness in 1997. Merck sells it under the brand name Propecia.This patent is set to expire in November 2013.

In December of 2008, the Swedish Medical Products agency concluded a safety investigation of Propecia. The Agency’s updated safety information lists difficulty in obtaining an erection that persists even after discontinuing Propecia as a possible side effect.

The Swedish Medical Products agency advise that use of Propecia may result in persistent sexual side effects. The agency lists difficulty in obtaining an erection even after discontinuation of Propecia as a possible side effect.

Recognized side effects, experienced by around >1% of users, include erectile dysfunction, and less often gynecomastia (breast gland enlargement).

Finasteride can cause borth defects in an unborn baby

Finasteride is not indicated for use by women. Finasteride is in the FDA pregnancy category X. This means that it is known to cause birth defects in an unborn baby. Women who are or who may become pregnant must not handle crushed or broken finasteride tablets, because the medication could be absorbed through the skin. Finasteride is known to cause birth defects in a developing male baby.

Benign Prostatic Hyperplasia

Benign prostatic hyperplasia (also called BPH) is a condition that affects the prostate gland in men. The prostate is a gland found between the bladder (where urine is stored) and the urethra (the tube urine passes through). As men age, the prostate gland slowly grows bigger (or enlarges). As the prostate gets bigger, it may press on the urethra and cause the flow of urine to be slower and less forceful. “Benign” means the enlargement isn’t caused by cancer or infection. “Hyperplasia” means enlargement.

Most symptoms of BPH start gradually. One symptom is the need to get up more often at night to urinate. Another symptom is the need to empty the bladder often during the day. Other symptoms include difficulty in starting the urine flow and dribbling after urination ends. The size and strength of the urine stream may decrease.

Before the Swissmedic approval, Aurobindo Pharma had secured a tentative approval from the U. S. Food and Drug Administration to sell its emtricitabine and tenofovir disproxil fumarate combination drug in tablet form. The anti-HIV drug is the generic version of Gilead Sciences Inc’s branded drug Truvada.

On the same day, Aurobindo Pharma got another nod for its Topiramate tablets in 25mg, 50mg, 100mg and 200mg strengths from the US Food and Drug Administration (US FDA).

The drug is generic equivalent of Ortho McNeil Janssen Pharmaceuticals’ Topamax tablets and indicated for the treatment of epilepsy in both children and adults.

Aurobindo Pharma Limited, headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, ANVISA Brazil. Aurobindo Pharma’s  product portfolio encompasses antibiotics, anti-retrovirals, CVS, CNS, gastroenterologicals, and anti-allergics. The company markets these products globally, in over 100 countries.