FDA approves 2 generics from VGYAAN Pharmaceuticals
Skillman, N.J.-based VGYAAN Pharmaceuticals has received regulatory approval for its fourth and fifth products.
The Food and Drug Administration has approved the company’s generics of Tegretol (carbamazapene tablets) and Lupron (leuprolide acetate injection).
The company’s leuprolide acetate injection was approved in multi-dose vials of 14 mg/2.8 ml. CEO Nailesh Bhatt said the approval is a testament to the company’s capabilities, as it is a combination product with considerable regulatory requirements. The product is indicated for use in the palliative treatment of advanced prostate cancer, and marks VGYAAN’s first injectable product.
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"This…approval adds an injectable drug to VGYAAN’s growing portfolio in our quest to provide high quality and affordable generic drugs to patients. This drug has experienced significant supply chain disruptions and shortages over the last few years, leading to high prices and quality issues. Therefore, we are especially looking forward to working with our valuable customers and channel partners to launch leuprolide acetate in the near future so we can help mitigate pain points.”
The company’s Tegretol generic is available in 200-mg dosage strength and is indicated for patients with partial, generalized tonic-clonic and mixed seizures, as well as certain types of nerve pain.
“We are very excited to receive our fifth product approval by the FDA for Carbamazepine,’ Bhatt said. “I want to thank our very talented and hardworking team for achieving this significant milestone in our young company’s journey, especially under these very challenging times during the pandemic this past year and a half. Our team is working diligently to launch Carbamazepine in the near future. In addition, we have multiple product applications with the FDA awaiting approvals in our quest to provide high quality, affordable generic drugs to patients.”