Alteon Discontinues Systolic Blood Pressure Study of alagebrium After...

PR Newswire;  June 9, 2005 ;     700+ words ...Announces FDA Clinical Hold on Further Enrollment...SPECTRA trial, a Phase 2b clinical trial for alagebrium...indicating that the drug has not demonstrated...and well-tolerated in clinical trials to date, the...Reproductive & Urologic Drug Products that further ...

Lift ED drug's clinical hold, Zonagen asks.(Brief Article)

Medical Marketing & Media;  June 1, 2000 ;     79 words ...* Hoping to have a clinical hold on development of its Vasomax and Vasofem lifted, Zonagen says...disorder. The Food and Drug Administration placed the programs on clinical hold last August because preliminary findings from the rat study...

A Stability Program for the Distribution of Drug Products

Pharmaceutical Technology;  July 1, 2004 ;     700+ words ...Drug products must be transported in a manner that...within the pharmaceutical supply chain. Drug products requiring controlled-temperature storage...those that focus on the distribution of drug products are addressed in this article. For...

Akorn, Inc. and FDC Limited Sign Exclusive Development and Supply...

M2 Presswire;  November 14, 2006 ;     700+ words ......Supply Agreement for Two Ophthalmic Suspension Drug Products(C)1994-2006 M2 COMMUNICATIONS LTD RDATE:14112006...supply agreement for two ophthalmic suspension drug products. The two drug products currently have a combined U.S. market size...

King Pharmaceuticals to Pay U.S. $124 Million For Medicaid Rebate...

U.S. Newswire;  November 1, 2005 ;     700+ words ......state governmental entities for its drug products, the Justice Department announced today...purchased the Bristol, Tenn., company's drug products will recover all underpaid rebates...that the prices they report on their drug products are truthful and accurate." "This settlement...

HHS Rule on Amendment of Monograph for OTC Decongestant Drug Products Sent...

US Fed News Service, Including US State News;  September 11, 2006 ;     112 words ......rule entitled "Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Amendment of Monograph for OTC Decongestant Drug Products." The document (RIN0910-AF34) (Docket No. 1976N-0052N) was received...

The FDA intends to take enforcement action against unapproved drug...

Medical Marketing & Media;  February 1, 2007 ;     30 words ...The FDA intends to take enforcement action against unapproved drug products containing quinine and persons who cause the manufacture of such products or their shipment in interstate commerce.

Telik Announces Clinical Hold on TELCYTA Trials.

PR Newswire;  June 5, 2007 ;     598 words ......Drug Administration (FDA) has placed a clinical hold on the Investigational New Drug (IND...TELCYTA(R) (canfosfamide HCl). The clinical hold was initiated by FDA following the...treatment until the FDA releases the clinical hold. Telik plans to submit to the FDA additional...

Olympic host cities pharmacies ordered to label drug products: SFDA

Xinhua News Agency;  April 18, 2008 ;     187 words ...Olympic host cities pharmacies ordered to label drug products: SFDA BEIJING, April 18 (Xinhua) -- Drugstores in six...events are required to clearly label the substances in drug products after May 1, China's pharmacy regulator said here on...

Kroger Removes Over-the-Counter Drug Products Containing PPA from Store...

PR Newswire;  November 8, 2000 ;     280 words ......shelves all over-the-counter (OTC) drug products containing phenylpropanolamine (PPA...notifying its stores to remove OTC drug products containing PPA from store shelves immediately...shelves. Those items include certain drug products sold under the Kroger and Perfect Choice...

FDA Maintains Clinical Hold on VaxGen's Anthrax Vaccine Trial.

PR Newswire;  December 18, 2006 ;     555 words ......company that it is maintaining its clinical hold on the company's second Phase II trial...formulation development. However, the clinical hold will remain in place until sufficient...over vaccine stability, to resolve the clinical hold imposed by FDA/CBER and to perform...

ViaCell Announces Clinical Hold Formalizing Suspension of Enrollment in...

PR Newswire;  September 21, 2005 ;     622 words ...-- Clinical Hold Not in Response to New Events...Administration (FDA) has placed a clinical hold on the Company's Phase I clinical...affected by a variety of cancers. The clinical hold is not in response to any new events...

AVAX Technologies Responds to Food and Drug Administration's Clinical Hold...

PR Newswire;  August 16, 2001 ;     643 words ......achieve a full release from the clinical hold. In addition to the work related to our response to the clinical hold, we have continued to aggressively...receiving full release from the clinical hold. AVAX Technologies is a biotechnology...

Labeling requirements for systemic antibacterial drug products intended...

M2 Presswire;  September 20, 2000 ;     455 words ......requirements for systemic antibacterial drug products intended for human use (C)1994-2000...proposed that all systemic antibacterial drug products intended for human use contain additional...labeling for systemic antibacterial drug products include certain statements about the...

Government Extends Deadline by Which VaxGen is Required to Resolve...

PR Newswire;  November 16, 2006 ;     540 words ......the company is required to resolve a clinical hold imposed by the Food and Drug Administration...Evaluation and Research had imposed a clinical hold on the company's forthcoming Phase...until November 13, 2006 to cure the clinical hold or the government would consider cancelling...