Zydus Pharma (USA) unveils Topiramate ER Capsules for epilepsy
It is also indicated for prophylaxis of migraine in patients 12 years of age and older.
Ahmedabad: Zydus Lifesciences Limited’s (formerly known as Cadila Healthcare Limited) subsidiary Zydus Pharmaceuticals (USA) Inc. (Zydus) has launched Topiramate Extended-Release Capsules.
The company had earlier received final approval from the United States Food and Drug Administration (USFDA) to market Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg (USRLD: Trokendi XR).
"Zydus is the first company to receive final approval and launch Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg in the United States," the company stated.
Topiramate Extended-Release capsule is indicated for Epilepsy: initial monotherapy in patients 6 years of age and older with partial-onset or primary generalized tonic-clonic seizures; adjunctive therapy in patients 6 years of age and older with partial onset, primary generalized tonic-clonic seizures, or seizures associated with Lenox-Gastaut Syndrome (LGS). It is also indicated for prophylaxis of migraine in patients 12 years of age and older.
Topiramate Extended-Release capsule had annual sales of USD 488mn in the United States according to IQVIA data (IQVIA MAT Nov. 2022).
Read also: Zydus Lifesciences bags USFDA nod for sleep disorder drug Triazolam
Zydus group is headquartered in Ahmedabad, India. The 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 in the high profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
The group has manufacturing capabilities across the entire pharmaceutical value chain: including formulations, APIs, vaccines, biosimilars, complex products (transdermals, topical etc.), animal health products and wellness products.
