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United States : FDA grants approval to PAR PHARMACEUTICAL for new drug application [TendersInfo (India)]


Par Pharmaceutical declared obtaining green nod from the US Food and Drug Administration (FDA) pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for its new drug application (NDA) for Vasostrict (vasopressin injection, USP) 20 units/mL This drug application is indicated to gain blood pressure in adults with vasodilatory shock who remain […]

China approves 1,000 drugs in 2010


BEIJING, Oct 10, 2011 (Xinhua via COMTEX) China’s food and drug watchdogsaid it approved 1,000 drug registration applications in 2010,26.2 percent more than in 2009 due to an increase in the approvalof generic chemicals.Among the approved drugs, chemicals represent the highestproportion at 89 percent, while Chinese traditional medicineaccounts for less than 10 percent of the […]

Consort Medical’s Bespak division wins contract for nasal drug delivery device


Oct 10, 2011 (Datamonitor via COMTEX) Consort Medical plc has announced that its Bespak division has received a development contract to deliver a nasal drug delivery device for a manufacturer of generic medicines. This is Bespak’s second nasal drug delivery device contract.Under the terms of the contract, Bespak will develop its Unidose nasal drug delivery […]

FTC Requires Sale of Generic Cancer Pain Drug and Muscle Relaxant as Conditions of Teva’s $6.8 Billion Acquisition of Cephalon


WASHINGTON, Oct. 7 The Federal Trade Commission issued the following news release:To protect competition in the market for prescription drugs, the Federal Trade Commission will require Teva Pharmaceutical Industries Ltd. to sell the rights and assets related to a generic cancer pain drug and a generic muscle relaxant, as a condition of its proposed $6.8 […]

PCMA on IOM Essential Health Benefits Report: Employers and Special Interests Will Spar Over Costly Prescription Drug Mandates


WASHINGTON, Oct. 7, 2011 /PRNewswire-USNewswire/ By urging the U.S. Department of Health and Human Services (HHS) to issue "Essential Health Benefits" regulations that ensure affordable, flexible benefits in the exchanges, the Institute of Medicine (IOM) has launched a long-overdue debate between employers and some powerful special interests that benefit from costly new mandates, according to […]

Guidance Now Available for Adding Products to OTC Drug Monograph System


by VARALAKSHMI PULUGURTHATargeted News ServiceWASHINGTON, Oct. 3 The U.S. Food and Drug Administration has issued a notice of the availability of a guidance program for industry entitled "Time and Extent Applications for Nonprescription Drug Products," according to Policy Acting Assistant Commissioner Leslie Kux.A summary of a notice in the Federal Register states: "This guidance describes […]

B.C. re-opens talks on lowering price of generic drugs for taxpayer and consumer


By Terri TheodoreVANCOUVER – Neither patients who buy generic drugs nor British Columbia taxpayers are saving the money they were promised on low-cost drug brands, so the provincial government is going back to the bargaining table.The government has served notice on the B.C. Pharmacy Association and the Canadian Association of Chain Drug Stores that it […]

Guidance for Industry on Time and Extent Applications for Nonprescription Drug Products; Availability


SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Time and Extent Applications for Nonprescription Drug Products." This guidance describes a two-step process on how to request that a new condition be added to the over-the-counter (OTC) drug monograph system. The process includes submitting a time and […]

Merck spent $1.1 million lobbying government in 2Q


WASHINGTON Drug maker Merck & Co. spent $1.12 million lobbying the federal government in the second quarter, on issues related to implementation of the health care overhaul and several tax-related matters, according to a quarterly disclosure report.That was up 19 percent from the $944,000 that the Whitehouse Station, N.J., company spent a year earlier.The maker […]

New Findings in Biochemistry Described from Fox Chase Cancer Center


A new study, "The benefits and challenges associated with the use of drug delivery systems in cancer therapy," is now available. "The use of drug delivery systems as nanocarriers for chemotherapeutic agents can improve the pharmacological properties of drugs by altering drug pharmacokinetics and biodistribution. Among the many drug delivery systems available, both micelles and […]