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FDA warns API manufacturer about river water as ingredient pharmafile
March 20, 2017
The FDA has issued Badrivishal Chemicals & Pharmaceuticals a warning letter regarding numerous violations of manufacturing codes.
AstraZeneca Receives Complete Response Letter from FDA for ZS-9 for Hyperkalaemia americanpharmaceuticalreview
March 20, 2017
AstraZeneca announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ZS-9 (sodium zirconium cyclosilicate).
FDA warns China's Lumis over misbranded APIs pharmafile
March 17, 2017
Chinese firm Lumis Global Pharmaceuticals became the latest to face the FDA’s ire as it was hit by a warning over its active pharmaceutical ingredient (API) facility in Hubei, China.
Proposed US budget for 2018 sees rise in FDA user fees to over $2 billion firstwordpharma
March 17, 2017
Under US President Donald Trump's proposed budget for 2018 released Thursday, the FDA would collect more than $2 billion in fees from industries that use its services...
Endo Releases Statement on FDA Advisory Committees' Vote Related to OPANA® ER americanpharmaceuticalreview
March 17, 2017
Endo International announced that the U.S. Food and Drug Administration's (FDA) Drug Safety Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees voted 18 to eight...
FDA Says Viberzi (eluxadoline) has an Increased Risk of Serious Pancreatitis in Patients without a G americanpharmaceuticalreview
March 17, 2017
The U.S. Food and Drug Administration (FDA) is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder.
GSK submits application to FDA for expanded indication of influenza vaccine pharmaceutical-technology
March 17, 2017
UK's GlaxoSmithKline (GSK) has submitted a supplemental biologics licence application (sBLA) to the US Food and Drug Administration (FDA) for expanded indication of its influenza vaccine, Fluarix Quadrivalent.
FDA panel says benefits of Endo's Opana ER no longer outweigh risks firstwordpharma
March 16, 2017
An FDA advisory committee voted 18 to eight with one abstention that the benefits of Endo International's reformulated Opana ER (oxymorphone) no longer outweigh its risks.
US FDA to lift import alert on Mohali plant financialexpress
March 16, 2017
The move will clear the path for Sun Pharma to supply approved products from the Mohali facility to the US market
FDA Approves Merck’s Keytruda (pembrolizumab) for Classical Hodgkin Lymphoma (cHL) drugs.com
March 15, 2017
Merck announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL).

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