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RSS FeedPosted by Michael Wonder on 02 Aug 2018
Acrux submits first-to-file application for generic version of Jublia making it eligible for 180 days of generic exclusivity
2 August 2018 - Acrux is pleased to announce that the US FDA has accepted for review the Paragraph IV Abbreviated ...
Posted by Michael Wonder on 20 Jul 2018
Statement from FDA Commissioner on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse
20 July 2018 - One of the ways that the U.S. FDA is working to address the opioid epidemic is ...
Posted by Michael Wonder on 20 Jul 2018
FDA provides scientific and regulatory clarity for generic drug developers through the issuance of 43 new or revised product-specific guidance documents, including hard-to-copy complex generics and abuse-deterrent formulations of opioids
20 July 2018 - The U.S. FDA today announced a new batch of product-specific guidances to support industry in identifying ...
Posted by Michael Wonder on 20 Jun 2018
Budget matters: infrastructure to support robust generic drug competition
18 June 2018 - The FDA launched its Drug Competition Action Plan more than a year ago, with the aim of ...
Posted by Michael Wonder on 14 Jun 2018
FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence
14 June 2018 - The U.S. FDA today approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film (applied ...
Posted by Michael Wonder on 14 Jun 2018
Mylan provides statement on generic Advair Diskus
13 June 2018 - On the afternoon of June 13, 2018, Mylan received an update from the U.S. FDA concerning ...
Posted by Michael Wonder on 31 May 2018
Statement from FDA Commissioner on new policies to reduce the ability of brand drug makers to use REMS programs as a way to block timely generic drug entry, helping promote competition and access
31 May 2018 - Our system for developing new drugs is based on a careful equilibrium enshrined in legislation by ...
Posted by Michael Wonder on 23 May 2018
Sun Pharma announces USFDA approval of Yonsa (abiraterone acetate) to treat metastatic castration-resistant prostate cancer in combination with methylprednisolone
23 May 2018 - Sun Pharma had acquired Yonsa from Churchill Pharmaceuticals and will commercialise Yonsa in the U.S. ...
Posted by Michael Wonder on 22 May 2018
Make drugs cheaper by encouraging generics
22 May 2018 - The FDA is pushing in that direction. Congress could do much more. ...
Posted by Michael Wonder on 17 May 2018
Statement from FDA Commissioner on new agency efforts to shine light on situations where drug makers may be pursuing gaming tactics to delay generic competition
17 May 2018 - No patients should be priced out of medicines they need to support their health. ...
Posted by Michael Wonder on 17 May 2018
Addressing generic drug market failures - the case for establishing a non-profit manufacturer
17 May 2018 - Robust competition usually keeps the price of generic drugs well below that of brand-name drugs. When ...
Posted by Michael Wonder on 15 May 2018
FDA to name companies accused of hindering generic drug development
14 May 2018 - On Thursday, the FDA plans to start publishing the names of pharmaceutical companies that have been ...
Posted by Michael Wonder on 13 May 2018
Perrigo expects complete response letter on generic version of ProAir
11 May 2018 - Perrigo today announced that it expects to receive a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 25 Feb 2018
Patients eagerly awaited a generic drug. Then they saw the price.
23 February 2018 - When Teva Pharmaceuticals announced recently that it would begin selling a copycat version of Syprine — ...
Posted by Michael Wonder on 13 Feb 2018
Sandoz announces US FDA approval and launch of Glatopa 40 mg/mL three times-a-week generic option for relapsing forms of multiple sclerosis
13 February 2018 - Glatopa 40 mg/mL is a fully substitutable, AP-rated generic version of Copaxone (glatiramer acetate injection) 40 mg/mL. ...