Cartelisation of drugs to stop: FDA

Assistance with U.S. FDA's Detention Without Physical Examination The Federal Food, Drug, and Cosmetic Act authorizes the U.S. Food and Drug Administration (FDA) to refuse admission of articles to U.S. that appear to be in violation of FDA ...

The U.S. Food and Drug Administration (FDA) announced this morning that Sandoz is conducting a voluntary recall of its Methotrexate Sodium USP, 25 mg/mL, 40 mL injectable products. The manufacturer discovered particulate matter in vials during a ...

Synageva BioPharma Corp. (Synageva) has announced that the US Food and Drug Administration (FDA) granted Breakthrough Therapy designation to sebelipase alfa for the treatment of early onset lysosomal acid lipase deficiency (LAL deficiency), also ...

The US Food and Drug Administration (FDA) has approved Janssen Biotech, Inc.'s Simponi (golimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have demonstrated corticosteroid dependence or who ...

The US Food and Drug Administration (FDA) has now issued a draft guideline on expanded access to investigational new drugs (IND) for treatment use in a 21 questions and answers format. The regulatory authority is now seeking the responses on this by ...

The advisory panel to the US Food & Drug Administration (FDA) will meet in mid-July 2013 to review QRxPharma's resubmitted application for its painkiller MoxDuo. In July 2012, the FDA refused to accept the drug on the grounds that it combined two ...

Aurobindo Pharma has received final approvals from the US Food and Drug Administration (US FDA) to manufacture and market tamsulosin hydrochloride capsules USP 0.4mg (ANDA 202433) and clindamycin palmitate hydrochloride for oral solution USP ...

Glenmark Generics Limited has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) with a Paragraph IV Certification, to sell generic version of Azelaic Acid, gel 15% topical.

Mylan Pharmaceuticals has started shipping fenofibrate tablets in two strengths after receiving final approval from the Food and Drug Administration, the Canonsburg company announced. Fenofibrate is the generic version of AbbVie Inc.'s Tricor, which ...