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Contract manufacturing drug firm Akums Drugs & Pharmaceuticals on Tuesday said DCGI has approved its formulation to treat certain types of seizures in patients with epilepsy. The approval allows Perampanel Oral Suspension to serve as adjunctive therapy for the treatment of partial-onset seizures (POS) with or without secondarily generalised seizures, as well as primary generalised tonic-clonic (PGTC) seizures in patients with epilepsy aged 12 years and older in the country, the company said in a statement. The company's product is a bioequivalent formulation of the USFDA-approved Fycompa (perampanel) Oral Suspension. India has more than 10 million patients with epilepsy, as per the company. "We are excited about the approval of Perampanel Oral Suspension, as it provides another treatment option for patients with epilepsy who may have difficulty swallowing tablets or prefer liquids," Akums Drugs & Pharmaceuticals Joint Managing Director Sanjeev Jain stated. The newly-approved ..
Zydus Lifesciences on Friday said it has launched generic epilepsy treatment medication in the US market. Zydus Pharmaceuticals (USA) Inc, a unit of the company, has launched Topiramate extended-release capsules in the American market. The company had earlier received final approval from the US Food and Drug Administration (USFDA) to market the product in strengths of USP 25 mg, 50 mg, and 100 mg, Zydus Lifesciences said in a statement. Zydus is the first company to receive final approval and launch the medication in the above mentioned strengths, it added. Topiramate extended-release capsules are indicated for epilepsy: initial monotherapy in patients who are six years of age and older with partial onset or primary generalized tonic-clonic seizures. It is also indicated for prophylaxis of migraine in patients 12 years of age and older. As per IQVIA data, Topiramate extended-release capsule had annual sales of USD 488 million in the US.