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.