FDA Archives - Page 8 of 19 - Lets Talk Health

FDA staff focus on Onyx cancer drug’s side effects

06/18/2012 majac Your Health Matters

WASHINGTON (Reuters) – U.S. drug reviewers said the serious heart, lung and liver side effects of Onyx Pharmaceuticals Inc’s carfilzomib drug may outweigh the experimental drug’s benefits for patients with a type of blood cancer. The Food and Drug Administration staff said about 22 percent of people taking the drug during a key clinical trial responded to the medicine, and many had severe side effects, meaning carfilzomib may not be better than older treatments for multiple myeloma. …

Drug Administration, FDA, Onyx Pharmaceuticals Inc

FDA reviews safety of innovative heart valve

06/11/2012 majac Your Health Matters

Federal health officials are asking safety questions about the first artificial heart valve designed to be implanted without major surgery, ahead of a meeting this week to consider broadening its use.

FDA

U.S. court revives KV Pharmaceutical investor suit

06/04/2012 majac Your Health Matters

(Reuters) – Investors can continue to bring claims against KV Pharmaceutical Co for making false or misleading statements to the U.S. Food and Drug Administration, a federal appeals court ruled on Monday. The 8th Circuit Court of Appeals largely revived a proposed securities fraud class action that had been dismissed in its entirety by a trial court in 2010. In the lawsuit, investors claimed to have suffered $1.5 billion in losses because KV, a generic drug maker, first misled the FDA in its compliance reports, and subsequently shut down its manufacturing operations in 2009. …

Drug Administration, FDA, KV

House votes to approve FDA funding bill

05/31/2012 majac Heart Disease

The FDA has been pushing for a uniform plan that would track individual vials of medicine. But companies, distributors and pharmacies say it may be too expensive, and propose an alternative plan that would track much larger "lots" of drugs.
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FDA

FDA warns about counterfeit Adderall tablets

05/31/2012 majac Your Health Matters

The Food and Drug Administration is warning consumers that a counterfeit version of the attention deficit hyperactivity disorder drug Adderall is being sold over the Internet.

Drug Administration, FDA

FDA warning hurts Hikma generics margins

05/17/2012 majac Your Health Matters

(Reuters) – Hikma Pharmaceuticals Plc said it expects profitability in its generics business to be hurt by continuing price competition and steps it has taken to comply with a warning letter from U.S. regulators. In February, the company received a warning letter from the U.S. Food and Drugs Administration (FDA) about operations at its Eatontown oral dosage facility in New Jersey. Hikma said it was enhancing its processes to address the regulator’s observations but the actions would slow sales in the first half. …

FDA, New Jersey

FDA approves new diet pill, some argue exercise still best

05/11/2012 majac Exercise

WINSTON-SALEM, NC — A panel of advisers to the Federal Food and Drug Administration have backed approval for the weight loss drug called Lorcaserin, but local doctors and exercise specialists are still skeptical of using drugs for weight loss.
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My Fox 8

Drug Administration, FDA

FDA delays rules meant to ease sunscreen confusion

05/11/2012 majac Your Health Matters

Sunscreen confusion won’t be over before summer after all. The government is bowing to industry requests for more time to make clear how much protection their lotions really offer.

FDA

FDA reviews first rapid, take-home test for HIV

05/11/2012 majac Your Health Matters

The Food and Drug Administration is considering approval of the first over-the-counter HIV test that would allow consumers to quickly test themselves for the virus at home, without medical supervision.

Drug Administration, FDA, HIV

FDA advisers recommend approving Arena weight–loss drug

05/10/2012 majac Your Health Matters

It is supposed to be used in combination with a healthy diet and exercise. Patients who started the locaserin trials lost an average of 5% of their weight; those who completed the studies lost an average of 8%, says company spokesman David Schull.
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USA TODAY

David Schull, FDA

FDA advisers recommend approving weight loss drug

05/10/2012 majac Your Health Matters

By LINDA A. JOHNSON AP Business Writer TRENTON, NJ—Advisers to government health regulators late Thursday recommended that they approve sales of what would be the first new prescription weight–loss drug in the US in more than a decade, despite …
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FDA, health, US

FDA panel backs first pill to block HIV infection

05/10/2012 majac Your Health Matters

The first drug shown to prevent HIV infection won the endorsement of a panel of federal advisers Thursday, clearing the way for a landmark approval in the 30-year fight against the virus that causes AIDS.

AIDS, FDA, HIV

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