Sun Pharma of India and Mylan Pharmaceuticals of West Virginia seek FDA approval of generic versions of the popular ...

The drug firm believes it is the first company to have filed a substantially-complete ANDA containing a Paragraph IV Certification for this product and expects to be eligible for 180 days of sole ...

Indies Pharma Jamaica Limited has made history as it became the first Jamaican company to get an ANDA (Abbreviated New Drug ...

The US Food and Drug Administration (FDA) yesterday announced revised final guidance for industry entitled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.” ...

Mumbai: Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug ...

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Wednesday told the U.S. District Court for the District of ...

Indies Pharma applied to the FDA in January 2023, for which a decision was expected in November, but received approval on ...

Aurobindo Pharma Ltd announced that its subsidiary, Eugia Steriles Private Limited, received its first product approval from ...

The FDA approved Lidocaine Hydrochloride Injection, USP, 1% (10 mg/mL) and 2% (20 mg/mL), Aurobindo Pharma said ...

Sun Pharma of India and Mylan Pharmaceuticals of West Virginia seek FDA approval of generic versions of the popular ...

Natco Pharma on Thursday said it has submitted a product application with the US health regulator for a generic product indicated for the treatment of metastatic non-small cell lung cancer.

The company has submitted an abbreviated new drug application (ANDA) containing a paragraph IV certification with the US Food and Drug Administration (FDA) for the generic version of Novartis' ...