USFDA nod to Zydus Lifesciences Migraine drug Topiramate Extended Release
The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.
Ahmedabad: Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and Drug Administration (USFDA) to market Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg (USRLD: Qudexy XR Extended-Release capsules).
Topiramate Extended-Release capsule is indicated to prevent and control seizures in people with epilepsy. It may also be used to prevent migraine headaches.
The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.
Topiramate Extended-Release capsule had annual sales of USD 68.8 mn in the United States, according to IQVIA data (IQVIA MAT Sep 2022). The group now has 335 approvals and has so far filed over 431* ANDAs since the commencement of the filing process in FY 2003-04.
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Medical Dialogues team had earlier reported that Zydus Lifesciences Limited's U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. had received final approval from the United States Food and Drug Administration (USFDA) to market Brivaracetam Tablets USP 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg.
Zydus Lifesciences Limited, formerly Cadila Healthcare Limited, is an Indian multinational pharmaceutical company headquartered in Ahmedabad. The company is primarily engaged in the manufacture of generic drugs. Zydus group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim in India and in the US and Brazil.
Zydus' global business has a strong presence in the regulated markets of the US, Europe (France and Spain), and the high-profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide
