The company previously received a complete response letter and intends to refile with the FDA in September

That drug, previously approved for cryopyrin-associated periodic syndrome (CAPS), received an 11-0 negative vote from the FDA's Arthritis Advisory Committee, and is expected to receive a complete response letter Monday

Earlier this month, the FDA accepted the company's resubmitted new drug application as a complete, Class 2 response to its May complete response letter on the drug

In March, the company received a complete response letter for Levadex

NuPathe originally filed for approval of the transdermal sumatriptan patch, known as Zelrix, in 2010, but the FDA issued a completed response letter last year, requesting additional information. (See BioWorld Today, Aug. 31, 2011

If the analyses are found sufficient to support drug approval, the FDA agreed to forego the additional confirmatory Phase III study requested in its 2009 complete response letter (CRL), according to Hemispherx

Contrave is currently in the LIGHT study, a large cardiovascular outcomes trial (CVOT) that the FDA required in a complete response letter

Chelsea has been seeking to regroup from the FDA's complete response letter for Northera in March...The FDA said the resubmission was a complete, Class 2 response to its complete response letter, dated Nov. 14, 2009

and Novartis AG bailed on their improved interferon drug Zalbin (albinterferon alfa-2b) in HCV after an FDA complete response letter citing concerns on the risk-benefit assessment. (See BioWorld Today, Oct. 6, 2010.) Still, the potential of the interferon space was lucrative enough to attract Bristol-Myers Squibb Co., which nabbed ZymoGenetics Inc

Nearly two years after a complete response letter (CRL) delayed Lux Biosciences Inc.'s plans for oral voclosporin in noninfectious uveitis, the Jersey City, N.J.-based biotech completed patient enrollment in a new Phase III study aimed at addressing the FDA's request for additional clinical data

Alexza Pharmaceuticals Inc., of Mountain View, Calif., said the FDA accepted its resubmitted Adasuve new drug application as a complete, Class 2 response to the May complete response letter

Vivus' Qnexa (phentermine/topiramate) has a PDUFA date of July 17 and Orexigen Therapeutics Inc.'s Contrave (naltrexone/bupropion) is in an FDA-required cardiovascular outcomes study to address a complete response letter

Inc. (Whitehouse Station, N.J.) Taltorvic Ridaforolimus Metastatic sarcoma FDA issued a complete response letter 6/7/12 Coronado Biosciences Inc. (Burlington, Mass.) CNDO-109 Activates the immune system's natural killer cells Acute myeloid leukemia FDA granted orphan drug status 6/20/12 Genentech Inc. (South San Francisco) Perjeta Pertuzumab HER2-positive breast cancer FDA approved it 6/12/12 Onyx Pharmaceuticals Inc. (South San Francisco) Kyprolis Carfilzomib Relapsed and refractory multiple

6/26/12 Boehringer Ingelheim GmbH (Ingelheim, Germany) Trajenta Linagliptin Type II diabetes Two-year study data showed it provided similar blood glucose improvements when compared to sulphonylurea glimepiride in patients inadequately controlled on metformin alone 6/29/12 Bristol-Myers Squibb Co. (New York) Eliquis Apixaban To prevent stroke and systemic embolism in nonvalvular atrial fibrillation FDA issued a complete response letter on the NDA 6/26/12 Bristol-Myers Squibb Co. (New York

In March, the FDA issued a complete response letter (CRL) for droxidopa after the agency's Cardiovascular and Renal Drugs Advisory Committee had given it a positive recommendation

It received a complete-response letter (CRL) in March 2010 due to issues related to manufacturing and the drug's risk evaluation and mitigation strategy

And Orexigen Therapeutics Inc.'s Contrave (naltrexone/bupropion), is currently in an FDA-required cardiovascular outcomes study after receiving a complete response letter last year. (See BioWorld Today, June 28, 2012 and Feb. 1, 2011.) But MacDougald was level-headed about how much work it would take to get there from here

And Orexigen Therapeutics Inc.'s Contrave (naltrexone/bupropion), is currently in an FDA-required cardiovascular outcomes study after receiving a complete response letter last year. (See BioWorld Today, June 28, 2012 and Feb. 1, 2011.) But MacDougald was level-headed about how much work it would take to get there from here

It received a complete-response letter (CRL) in March 2010 due to issues related to manufacturing and the drug's risk evaluation and mitigation strategy