Aurobindo said that the grant is its 9th product approval from Health Canada. The Topiramate Tablet 25mg, 50mg, 100mg and 200mg is the generic equivalent of Janssen-Ortho, Canada’s Topamax Tablets 25mg, 50mg, 100mg & 200mg. Topiramate Tablets are indicated as adjunctive therapy for patients with partial onset seizures or primary generalized tonic-clonic seizures and falls under the Central Nervous System (CNS) therapeutic category.
Topiramate is an oral drug that is used to prevent the seizures of epilepsy. It is used primarily among patients who are not controlled by other anti-epileptic drugs. About 1 in 4 Americans diagnosed with epilepsy has seizures that resist treatment with other anti-epileptic drugs. Topiramate also prevents migraine headaches.
Headquartered at Hyderabad, India, Aurobindo Pharma, 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.
The company’s product portfolio is spread over six major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergics, supported by an outstanding R&D set-up. The company is marketing these products globally, in over 125 countries.