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Latest Generic drug Stories

2014-09-30 23:23:50

For generic drugmakers, Oct. 1 is crunch time, the date after which all ANDA amendment and prior-approval supplement applications must meet new performance goals under the Generic Drug User Fee Amendments (GDUFA) of 2012. Joan Janulis, a Hatch-Waxman pro and all-around expert on FDA regulation in the generic drug industry, will help attendees read between the lines of the GDUFA performance metrics, associated guidance documents and MAPPs, and provide a roadmap to the post-GDUFA paradigm....

2014-09-30 08:32:14

DUBLIN, Sept. 30, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that it intends to release third quarter 2014 financial results on Wednesday, November 5, 2014, prior to the open of the U.S. financial markets. The Company will host a conference call and webcast at 8:00 a.m. Eastern Standard Time on Wednesday, November 5, 2014 to discuss its financial results. The dial-in number to access the call is U.S./Canada (877) 251-7980, International (706) 643-1573, and the...

2014-09-25 16:26:46

DUBLIN, Sept. 25, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Buprenorphine Transdermal System, 5 mcg/hr, 10 mcg/hr and 20 mcg/hr. Actavis' ANDA product is a generic version of Purdue Pharma's Butrans(®), which is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for...

2014-09-25 08:27:49

BUENA, N.J., Sept. 25, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based specialty generic pharmaceutical company, today announced it has acquired the regulatory rights and related documents and records for 18 drug products from AstraZeneca, 17 of which were marketed. The acquisition includes the regulatory rights and documents for 17 injectable products and 1 suppository product. All of these products had been previously approved by the US FDA as...

2014-09-24 12:26:06

WASHINGTON, Sept. 24, 2014 /PRNewswire-USNewswire/ -- "When President Ronald Reagan signed the Drug Price Competition and Patent Term Restoration Act 30 years ago today, few could imagine how the law would transform the healthcare landscape. Today, we know that this landmark 'Hatch-Waxman' legislation is responsible for improving the lives of millions of Americans by creating a new framework allowing safe, affordable generic drugs to come to the market. It is instructive to look...

2014-09-21 23:01:02

The expansion of Canadian's access to primary healthcare services will bolster demand for pharmaceuticals. For these reasons, industry research firm IBISWorld has added a report on the Brand Name Pharmaceutical Manufacturing industry to its growing industry report collection. New York, NY (PRWEB) September 21, 2014 Over the past five years, the patent cliff has enabled more generic drugs to inundate the market, thereby cutting into revenue growth for the Brand Name Pharmaceutical...

2014-09-10 23:08:02

The Alabama Supreme Court ruled that brand-name drug companies can be sued for injuries caused by its generic equivalent if the brand-name manufacturer made misleading or inaccurate claims about the drug, and those claims were relied upon by the injured person’s physician; this decision confirms the court’s previous ruling last year. Port Washington, New York (PRWEB) September 10, 2014 Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by...

2014-09-10 12:24:20

Ten-year savings hits record at nearly $1.5 trillion according to annual Generic Drug Savings in the U.S. report WASHINGTON, Sept. 10, 2014 /PRNewswire-USNewswire/ -- The Generic Pharmaceutical Association (GPhA) today released a report showing that generic drugs saved the United States health system $239 billion in 2013, a 14% increase over cost savings achieved in 2012, and the largest annual savings to date. The report also calculates that generic medications saved a record of nearly $1.5...

2014-09-08 12:29:59

Commission Alleges That AbbVie Inc. and Besins Healthcare Inc. Filed Sham Lawsuits; AbbVie and Teva Pharmaceuticals USA, Inc. Entered Anticompetitive Agreement to Delay Generic Entry WASHINGTON, Sept. 8, 2014 /PRNewswire-USNewswire/ -- In its latest action to ensure competition in the nation's healthcare markets, the Federal Trade Commission has filed a complaint in federal district court charging several major pharmaceutical companies with illegally blocking American consumers' access to...

2014-09-08 08:29:19

Mylan Free to Immediately Resume Distribution of Its Generic Precedex Product PITTSBURGH, Sept. 8, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today commented on a ruling by the U.S. District Court for the District of Maryland related to its product, Dexmedetomidine Hydrochloride Injection, 100 mcg (base)/mL, packaged in 200 mcg (base)/2 mL Single-dose Vials, which was approved by the U.S. Food and Drug Administration (FDA) as therapeutically equivalent to Hospira Inc.'s...


Word of the Day
caparison
  • A cloth or covering, more or less ornamented, laid over the saddle or furniture of a horse, especially of a sumpter-horse or horse of state.
  • Clothing, especially sumptuous clothing; equipment; outfit.
  • To cover with a caparison, as a horse.
  • To dress sumptuously; adorn with rich dress.
This word ultimately comes from the Medieval Latin 'cappa,' cloak.
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