FDA releases draft of GDUFA goals
WASHINGTON — Following months of meetings and negotiations with the drug and chemical industries, the Food and Drug Administration has released a draft of the goals of the Generic Drug User Fee Act.
The act, which still requires approval from Congress, would give the FDA $1.5 billion over five years through industry user fees. The law, also known as GDUFA, has long been a goal of the generic drug industry, which sees it as a way of expediting the agency’s review of generic drugs and whittling down its massive backlog of thousands of applications currently awaiting review and taking action on 90% of the generic drug approval applications within 10 months after the date of submission. The law also would enhance the FDA’s ability to inspect foreign manufacturing sites; according to the Government Accountability Office, the FDA was able to conduct good manufacturing practice inspections at 11% of the foreign sites in its database, compared with 40% of domestic sites.
"The Generic Drug User Fee Act is a milestone for the generic drug industry and a major win for American healthcare consumers," Generic Pharmaceutical Association president and CEO Ralph Neas said. "This program, as negotiated, will result in expedited access to low-cost, high-quality generic drugs for Americans and will further safeguard the quality and accessibility of our nation’s drug supply."
So who gets to pay the User Fee ?
FDA approves painkiller made by Sun Pharmaceutical Industries
MUMBAI, India — The Food and Drug Administration has approved a generic painkiller made by Sun Pharmaceutical Industries, Sun said.
Sun announced the approval of tramadol hydrochloride extended-release tablets, a generic version of Valeant International’s Ultram ER. The drug is used to treat moderate to moderately severe chronic pain in adults who need constant treatment for an extended period of time.
Various versions of the drug have annual sales of $125 million, according to Sun.
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FDA approves crush-resistant painkiller by Endo
CHADDS FORD, Pa. — The Food and Drug Administration has approved a new formulation of a painkiller made by Endo Pharmaceuticals designed to thwart drug abuse, Endo said Monday.
Endo announced the FDA’s approval of a crush-resistant version of Opana ER (oxymorphone). Drug abusers often crush opioid pills in order to smoke, inhale or inject them. Endo developed the new formulation of the drug, scheduled for launch in 2012, using Grunenthal’s Intac technology. The new version will otherwise be identical to the old one.
"FDA’s approval of this new formulation of Opana ER is an important milestone for both the long-acting opioid category as well as Endo’s branded pharmaceutical portfolio," Endo EVP research and development and chief scientific officer Ivan Gergel said. "Patient safety is our top concern, and addressing appropriate use of opioids is a responsibility that we take very seriously."
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