The drugs we use as prescribed by doctors represent the product approved by the FDA for a specified medical use under its NDA or BLA. Let’s take a look at some of the technical definitions ...

has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Raltegravir Tablets USP, 600 mg," company said in its press ...

Mumbai: Global pharma major Lupin Limited has announced that the company has launched Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 600 mg, and 800 mg, following the approval of its Abbreviated New ...

This version targets partial-onset seizures, a prevalent condition, extending much-needed affordability. Lupin's market entry follows the approval of its abbreviated new drug application (ANDA) from ...

Drug firm Lupin Limited on Wednesday (May 7) said it has launched eslicarbazepine acetate tablets in the US after securing approval from the US Food and Drug Administration (FDA) for its abbreviated ...

Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "Our recent new drug application filings for tradipitant and Bysanti are a testament to our productive research and ...

Senores Pharmaceuticals is set to acquire Wockhardt's USFDA-approved ANDA for Topiramate tablets, a medication used for epilepsy and migraine treatment. This acquisition, valued at USD 111.47 million ...

Ahmedabad-based Senores Pharmaceuticals Limited has announced that it has entered into an agreement with Wockhardt Ltd to acquire the latter's US FDA approved Abbreviated New Drug Application (ANDA) ...

USA, has signed an agreement to acquire the USFDA-approved Abbreviated New Drug Application (ANDA) for Topiramate HCl 25, 50, 100, and 200 mg tablets from Wockhardt. Topiramate is indicated for ...

The US Court of Appeals for the Federal Circuit affirmed a district court’s noninfringement determination, finding that the presence of a disclaimed compound in the accused product precluded ...