FDA seizes 538 adulterated bags of tea powder

The food and drug administration (FDA) on Tuesday seized 538 adulterated bags of tea powder from Ponda resident Mohammed Ilyas Ahmed's Usgao go,down.

Each bag weighs 5 kg and is worth around ` 3,76,600 totally. FDA inspectors Abel Rodrigues, Rajaram Patil and Shraddha Kutikar conducted the raid.

The FDA has filed a case under the Prevention of Food Adulteration (PFA) Act, 1955.

According to FDA director Salim Veljee, Ahmed was to receive a consignment of adulterated 'Sona' and 'Ruby' tea powder from Shimoga in Karnataka.

Veljee said Ahmed runs a proprietorship firm in Shimoga under the name of Sona Enterprises and books consignments of tea powder for Goan firms with bogus names.

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Integra LifeSciences gets FDA approval for 3 new spinal implant devices

Medical device maker Integra LifeSciences Holdings Corp. said Monday it has received clearance from the Food and Drug Administration to market three new spinal implant devices.

The devices are small hollow spinal implants that are inserted between vertebrae to restore the space between discs, relieving nerve pressure and back pain by maintaining the natural disc space height. The devices have a graft window to allow natural bone growth to occur through them and form a strong connection that incorporates the implant.

The devices are aimed at spinal surgery and are currently in limited commercial release, the company said. It plans on full commercial release later in 2011.

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FDA Okays First Dengue Fever Test

The FDA has cleared the first test to diagnose patients with signs and symptoms of dengue fever.

 

The test, known as the DENV Detect IgM Capture ELISA, looks for dengue virus antibodies in blood samples of patients who are symptomatic for the fever.

There are no tests currently cleared or approved by the FDA for direct detection of dengue virus.

The new test's clearance was made possible through an alternate marketing path known as the de novo pathway, which allows for marketing of new devices that are low to moderate risk in use and that may not require premarket approval, an FDA statement said.

The test should not be used on patients who are asymptomatic, the statement said.

The agency warned that test results can be complicated by the IgM antibody response to dengue virus, which doesn't occur until three to five days after the fever's onset, meaning that the test may show a negative result despite infection.

The test may also react to related viruses -- such as that responsible for West Nile disease -- but in U.S. testing results, patients that showed signs of dengue should be considered to show presumptive evidence of dengue, according to the agency.

The test is made by Inbios, of Seattle.

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FDA to Review Indacaterol’s Clinical Trial Again

Crushing the dreams of the pharmaceutical giant Novartis AG, the US Food and Drug Administration (FDA) has scraped away the company’s launch for Indacaterol, a drug meant for curing lungs related ailments.

The bosses at the FDA have asked for the extended period of three months to go through the findings of the clinical trial that involved indacaterol.

The drug was waivered by the FDA after some safety risks surrounding the medicine cropped up.

Stating in this context, Trevor Mundel, the Head of Development for Novartis, asserted: "This three-month extension reflects discussion at the advisory committee based on the comprehensive clinical program resulting in a large amount of data to be reviewed”.

The drug is basically for the treatment of the chronic obstructive pulmonary disease (COPD).

The findings of the phase III trial were released in March last year and had claimed that the drug was significantly more effective than formoterol that is needed to be taken twice in a day.

It is learnt that COPD is a lethal disease that claims more than 120,000 lives each year.

Interestingly, the drug has been legally approved in Europe and is sold under the name of Onbrez.

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FDA puts RegeneRx clinical trial on hold

The Food and Drug Administration has slammed the breaks on clinical trials for RegeneRx Biopharmaceuticals Inc.’s injectable heart attack drug.

Regulators put mid-stage trials on an indefinite hold due to non-compliance by one of its contractors with Good Manufacturing Practice standards, a set of quality and safety regulations governing pharmaceutical manufacture.

The Rockville biotech firm planned to begin enrolling patients for the Phase 2 trial of the compound, RGN-352, within weeks. Phase 1 trials of the drug had yielded positive results.

The FDA’s hold is related to problems at a contract site and does not pertain to the overall safety of its drug candidate, the company said in a news release. As a “virtual company,” RegeneRx relies heavily on outsourcing to bring its products through the clinic.

The setback represents the latest difficulty for the biotech, which was delisted from the New York Stock Exchange in December.

The company last year won a $3 million National Institutes of Health grant to fund research for the heart attack drug.

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