Aurobindo to launch schizophrenia drug risperidone in US

Aurobindo received the final regulatory clearance for risperidone oral solution 1mg/mL form US FDA, Aurobindo said in a press statement.

Aurobindo’s generic risperidone is the is therapeutic equivalent to Risperdal oral solution 1mg/mL of Ortho-McNeil Janssen.

Risperidone is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. In 1993 USFDA approved risperidone for the treatment of schizophrenia. Risperdone was also approved as the only treatment of schizophrenia for the age-group 13–17, by USFDA.

Rispiridone was also given approval for treatment of bipolar disorder children belonging ages 10–17, on August 22, 2007. Risperidone has a market size of approximately US$ 68 million for the twelve months ending March 2009 according to Newport.

Rrisperidone is not approved for the treatment of patients with dementia-related psychosis. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients.

Resperidone generic approval takes Aurobindo’s total number of abbreviated new drug applications (ANDA) approvals from US FDA to 102 mark, Aurobindo said.

Last week, Aurobindo Pharma Ltd received approval for the antibiotic clindamycin hydrochloride capsules from the US Food and Drug Administration. Aurobindo’s clindamycin hydrochlorie is a generic equivalent of Pfizer’s Cleocin hydrochloride capsules. Clindamycin is used to treat certain bacterial infections.

Cleocin has a market size of about $55 million, the company said in a statement to the stock exchange. Aurobindo Pharma received USFDA approval for sumatriptan succinate Tablets 25 mg, 50 mg, and 100 mg – the generic equivalent of GlaxoSmithKline’s Imitrex Tablets 25mg, 50mg 100mg and are indicated for the treatment of for the treatment of acute migraine headaches and falls under the Central Nervous System (CNS) therapeutic segment, recently.

Headquartered at Hyderabad, India, Aurobindo Pharma Limited is the largest Active Pharmaceutical Ingredients (API) manufacturer under FDA approved facility. Aurobindo is also one of the leading manufacturers of penicillin & cephalosporine products.

Aurobindo’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, ANVISA Brazil. Aurobindo is leading manufacturer of generic pharmaceuticals, as well.

Aurobindo’s product portfolio is spread over 6 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergics.

Aurobindo is marketing these products in over 100 countries.

Recently, Aurobindo’s wholly owned subsidiary Aurobindo Pharma Australia Pty Ltd has received its third approval from the Therapeutic Goods Administration (TGA), Government of Australia for the registration of simvastatin Tablets 5, 10, 20, 40 & 80 mg tablets.

Aurobindo Pharma received approval from Swissmedic, Government of Switzerland for the license of Cefepime APL for Injection 1g and 2g. Cefepime APL for Injection 1g and 2g falls under the anti-beta-lactam segment and is indicated for Moderate to severe pneumonia, septicaemia, UTI, skin & skin structure infections, intra-abdominal infections. This is Aurobindo’s second product approval from Swissmedic. Earlier, Aurobindo received the license of Finasteride APL Tablets 5mg.

Aurobindo registered a total operating income of Rs 3124.2 crores for the financial year 2008-09, up by 27.7% from Rs 2446.5 crores in the corresponding period last year. The operating profit before Fx stood at Rs 573.2 crores up by 63.0% compared to Rs 351.7 crores, a year ago. During the year, the company has incurred Fx loss of Rs 254.7 crores, which includes loss due to restatement of Foreign Currency Convertible Bonds (net of deposits) of Rs 223.3 crores (gain of Rs 49.6 crores).

Aurobindo expanded its formulation deal with Pfizer in April. Through the pact Pfizer acquired rights to 55 solid oral dose products and five sterile injectable products that it will sell in several countries throughout Asia, Latin America, Africa and the Middle East.