New Drug Application News and Research

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FDA accepts Iroko's submicron indomethacin NDA for treatment of acute pain in adults

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to scientific advancements in analgesia, announced that the U.S. Food and Drug Administration has accepted for review the New Drug Application for lower dose submicron indomethacin, a non-steroidal anti-inflammatory drug, for the proposed indication of treatment of mild to moderate acute pain in adults.

16 Jul 2013

Actavis’ Lamictal ODT drug receives FDA approval for treatment of epilepsy and bipolar disorder

Actavis, Inc. (NYSE: ACT) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Lamotrigine Orally Disintegrating Tablets, 25 mg, 50 mg, 100 mg and 200 mg, a generic equivalent to GlaxoSmithKline's Lamictal® ODT.

16 Jul 2013

Furiex Pharmaceuticals enrolls patient for Phase III clinical trial of eluxadoline for treatment of diarrhea

Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today announced completion of patient enrollment in the company's two ongoing Phase III clinical trials studying eluxadoline for the treatment of diarrhea-predominant irritable bowel syndrome, or IBS-d. Both studies met their target enrollments and Furiex expects to release top line results in the first quarter of 2014.

16 Jul 2013

Actavis receives FDA approval for Opana ER tablets

Actavis, Inc. (NYSE: ACT) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Oxymorphone Hydrochloride Extended-release Tablets, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg.

15 Jul 2013

Alnylam releases positive top-line data from ALN-TTRsc Phase I trial for TTR-mediated amyloidosis

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today positive top-line results from its ongoing Phase I trial of ALN-TTRsc, a subcutaneously administered RNAi therapeutic targeting the transthyretin gene for the treatment of TTR-mediated amyloidosis.

12 Jul 2013

Bristol-Myers Squibb, Pfizer announce FDA acceptance of Eliquis sNDA for review

Bristol-Myers Squibb Company and Pfizer Inc. today announced that the U.S. Food and Drug Administration has accepted for review a Supplemental New Drug Application for Eliquis (apixaban), for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism, in adult patients who have undergone hip or knee replacement surgery.

11 Jul 2013

Pharmacyclics submits ibrutinib NDA to FDA for two B-cell malignancies

Pharmacyclics, Inc. today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for the investigational oral Bruton's tyrosine kinase inhibitor, ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma.

10 Jul 2013

Omthera submits Epanova NDA to FDA for treatment of severe hypertriglyceridemia

Omthera Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of Epanova™ for the treatment for patients with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500mg/dL).

9 Jul 2013

Alnylam Pharmaceuticals presents new pre-clinical data of ALN-AT3 at ISTH meeting

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has presented new pre-clinical data from its RNAi therapeutic program for the treatment of hemophilia and rare bleeding disorders.

2 Jul 2013

UCLA researchers introduce gene therapy technique to treat sickle cell disease

Researchers at UCLA's Eli & Edythe Broad Center of Regenerative Medicine & Stem Cell Research have successfully established the foundation for using hematopoietic (blood-producing) stem cells from the bone marrow of patients with sickle cell disease to treat the disease.

2 Jul 2013

FDA sends Complete Response Letter to Merck regarding investigational drug for insomnia

Merck, known as MSD outside the United States and Canada, announced today that the company has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application for suvorexant, Merck's investigational medicine for the treatment of insomnia.

2 Jul 2013

Bayer, Onyx submit sNDA to FDA, marketing authorization application to EMA for Nexavar tablets

Bayer HealthCare and Onyx Pharmaceuticals today announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration and an application for marketing authorization to the European Medicines Agency for the oral multi-kinase inhibitor Nexavar (sorafenib) tablets for the treatment of locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer.

1 Jul 2013

Federal judge orders permanent injunction against Med Prep Consulting

A federal judge from the U.S. District Court for New Jersey has entered a consent decree of permanent injunction against Med Prep Consulting, Inc., a pharmacy licensed by the state of New Jersey, and Gerald R. Tighe, the company's president and owner.

29 Jun 2013

Janssen receives complete response letter from FDA for XARELTO sNDA

Janssen Research & Development, LLC today announced the U.S. Food and Drug Administration has issued a complete response letter for the supplemental New Drug Application for XARELTO (rivaroxaban) to reduce the risk of stent thrombosis in patients with acute coronary syndrome.

28 Jun 2013

Sprout Pharmaceuticals resubmits flibanserin NDA for treating HSDD in pre-menopausal women

Sprout Pharmaceuticals, the Raleigh-based pharmaceutical company developing flibanserin, a treatment being evaluated for Hypoactive Sexual Desire Disorder in pre-menopausal women, confirmed today that the company has resubmitted the New Drug Application for flibanserin earlier this year and expects US Food and Drug Agency action before the end of 2013.

27 Jun 2013

Mylan Pharmaceuticals launches generic version of Micronor Tablets

Mylan Inc. today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Norethindrone Tablets USP, 0.35 mg.

26 Jun 2013

Sanofi presents positive phase 3 data for GLP-1 receptor for type 2 diabetes

Sanofi US (EURONEXT: SAN and NYSE: SNY) announced today data that showed lixisenatide, an investigational once-daily prandial glucagon-like peptide 1 (GLP-1) receptor agonist, decreased HbA1c by reducing PPG (postprandial glucose) daytime exposure when added to standard of care which includes basal insulin with or without oral anti-diabetic agents (OADs). Lixisenatide is for the treatment of adults with type 2 diabetes mellitus.

24 Jun 2013

Alnylam presents new pre-clinical data of ALN-CC5 for treatment of complement-mediated diseases

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has presented new pre-clinical data with ALN-CC5, an RNAi therapeutic targeting complement component C5.

21 Jun 2013

FDA accepts DURECT's New Drug Application for POSIDUR

DURECT Corporation today announced that the New Drug Application for the investigational product POSIDUR (SABER-Bupivacaine) has been accepted by the U.S. Food and Drug Administration indicating that the application is sufficiently complete to permit a substantive review.

20 Jun 2013

Vanda presents additional data from tasimelteon Phase III studies at ENDO 2013

Vanda Pharmaceuticals Inc. presented additional data today at ENDO 2013, the Endocrine Society's 95th Annual Meeting, demonstrating that tasimelteon can entrain (synchronize) both melatonin and cortisol rhythms.

18 Jun 2013

New Drug Application News and Research

FDA accepts Iroko's submicron indomethacin NDA for treatment of acute pain in adults

Actavis’ Lamictal ODT drug receives FDA approval for treatment of epilepsy and bipolar disorder

Furiex Pharmaceuticals enrolls patient for Phase III clinical trial of eluxadoline for treatment of diarrhea

Actavis receives FDA approval for Opana ER tablets

Alnylam releases positive top-line data from ALN-TTRsc Phase I trial for TTR-mediated amyloidosis

Bristol-Myers Squibb, Pfizer announce FDA acceptance of Eliquis sNDA for review

Pharmacyclics submits ibrutinib NDA to FDA for two B-cell malignancies

Omthera submits Epanova NDA to FDA for treatment of severe hypertriglyceridemia

Alnylam Pharmaceuticals presents new pre-clinical data of ALN-AT3 at ISTH meeting

UCLA researchers introduce gene therapy technique to treat sickle cell disease

FDA sends Complete Response Letter to Merck regarding investigational drug for insomnia

Bayer, Onyx submit sNDA to FDA, marketing authorization application to EMA for Nexavar tablets

Federal judge orders permanent injunction against Med Prep Consulting

Janssen receives complete response letter from FDA for XARELTO sNDA

Sprout Pharmaceuticals resubmits flibanserin NDA for treating HSDD in pre-menopausal women

Mylan Pharmaceuticals launches generic version of Micronor Tablets

Sanofi presents positive phase 3 data for GLP-1 receptor for type 2 diabetes

Alnylam presents new pre-clinical data of ALN-CC5 for treatment of complement-mediated diseases

FDA accepts DURECT's New Drug Application for POSIDUR

Vanda presents additional data from tasimelteon Phase III studies at ENDO 2013

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