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Impax announces submission of EMA Marketing Authorization Application for IPX066

Impax Laboratories (Netherlands) B.V., a wholly owned subsidiary of Impax Laboratories, Inc. today announced that it has submitted a Marketing Authorization Application for IPX066 to the European Medicines Agency. IPX066 is an investigational extended-release capsule formulation of carbidopa-levodopa for the treatment of idiopathic Parkinson's disease.

6 Nov 2014

Mylan announces U.S. launch of generic Loestrin 24 Fe

Mylan Inc. today announced the U.S. launch of its Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate, which is the generic version of Warner Chilcott's Loestrin 24 Fe.

5 Nov 2014

Glenmark gets final approval from FDA for Omeprazole DR Capsules ANDA

Glenmark Generics Inc. USA, the subsidiary of Glenmark Generics Limited, has been granted final approval for its abbreviated new drug application (ANDA) from the United States Food and Drug Administration for Omeprazole Delayed Release Capsules, their generic version of Prilosec by AstraZeneca.

5 Nov 2014

Avanir Pharmaceuticals to publish AVP-825 phase III study results in the journal 'Headache'

Avanir Pharmaceuticals, Inc. today announced the publication of results from TARGET, a pivotal phase III study evaluating the efﬁcacy and safety of AVP-825 22mg in the January 2015 issue of Headache (Early access is now available).

30 Oct 2014

FDA recommens approval of Daiichi Sankyo's once-daily SAVAYSA for patients with NVAF

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the U.S. Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee voted 9 to 1 to recommend approval of once-daily SAVAYSA (edoxaban) 60 mg dosing regimen for the reduction in risk of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF).

30 Oct 2014

Neurocrine Biosciences' NBI-98854 drug gets breakthrough designation for tardive dyskinesia

Neurocrine Biosciences, Inc. announced today that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for its Vesicular Monoamine Transporter 2 inhibitor, NBI-98854, in tardive dyskinesia.

30 Oct 2014

Auxilium Pharmaceuticals reports total revenues of $109.6 million for Q3 2014

Auxilium Pharmaceuticals, Inc., a fully integrated specialty biopharmaceutical company, today announced financial results for the third quarter ending September 30, 2014.

30 Oct 2014

TWi Pharmaceuticals obtains final ANDA approval for Donepezil Hydrochloride Tablets USP, 23 mg

TWi Pharmaceuticals, Inc. today announced that it has received final approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Donepezil Hydrochloride Tablets USP, 23 mg, the generic equivalent to Eisai Inc.'s Aricept 23mg.

30 Oct 2014

Vanda reports total revenues of $14.8 million for third quarter 2014

Vanda Pharmaceuticals Inc., today announced financial and operational results for the third quarter ended September 30, 2014.

27 Oct 2014

Regulus Therapeutics demonstrates human proof-of-concept with microRNA therapeutic

Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that it has demonstrated human proof-of-concept with a microRNA therapeutic from an ongoing clinical study evaluating RG-101, a wholly-owned, GalNac-conjugated anti-miR targeting microRNA-122 (“miR-122”), for the treatment of hepatitis C virus infection (“HCV”).

22 Oct 2014

FDA accepts Eisai's sNDA for perampanel drug for treatment of PGTC seizures

Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) accepted for review the company's Supplemental New Drug Application (sNDA) for its in-house-discovered AMPA receptor antagonist perampanel for the treatment of primary generalized tonic-clonic (PGTC) seizures.

20 Oct 2014

Janssen announces submission of IMBRUVICA sNDA to FDA for WM treatment

Janssen Research & Development, LLC today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA (ibrutinib) to the U.S. Food and Drug Administration by its strategic partner Pharmacyclics, Inc.

20 Oct 2014

Actavis seeks FDA approval to market generic version of Quillivant XR

Actavis plc today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market Methylphenidate Hydrochloride for Extended-release Oral Suspension, 5 mg/mL. Actavis' ANDA product is a generic version of Pfizer and Tris Pharma's Quillivant XR®, which is a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder.

16 Oct 2014

Highland completes US$25 million offering of Class A Common Shares

Highland Therapeutics Inc., a pharmaceutical company, today announced it has completed a US$25 million offering of Class A Common Shares. The financing was led by a private equity partner that is committed to Highland's long-term success.

16 Oct 2014

Eisai, Helsinn Group announce FDA approval of AKYNZEO for prevention of CINV

Helsinn Group and Eisai Inc. announced today that the Food and Drug Administration (FDA) approved AKYNZEO® for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

13 Oct 2014

Shire receives FDA guidance on regulatory path for investigational compound SHP 465

Shire plc today announced that it has received further guidance from the U.S. Food and Drug Administration on the regulatory path for SHP 465 (triple-bead mixed amphetamine salts MAS), an investigational oral stimulant medication being evaluated as a potential treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) in adults.

9 Oct 2014

Isavuconazole demonstrates successful outcomes in treatment of mucormycosis

Astellas reported today that isavuconazole demonstrated successful outcomes in the treatment of mucormycosis according to data from the phase 3 isavuconazole VITAL study being presented at IDWeek on October 10, 2014, in Philadelphia, Pa.

8 Oct 2014

Par Pharmaceutical starts shipping generic version of Exforge

Par Pharmaceutical Companies, Inc. today announced that it has begun shipping all four strengths of amlodipine and valsartan tablets, the generic version of Novartis' Exforge. Par received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for amlodipine and valsartan and was granted 180 days of marketing exclusivity.

30 Sep 2014

Bausch + Lomb’s sub-micron loteprednol etabonate ophthalmic gel meets primary endpoint

Bausch + Lomb, a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX), today announced that its next generation sub-micron gel formulation of loteprednol etabonate was statistically superior to placebo (vehicle gel) in eliminating inflammation and pain following cataract surgery by study day eight, the primary endpoints in the first Phase 3, multi-center, double-masked, vehicle-controlled, parallel-group study.

30 Sep 2014

Guerbet wins Drug Shortage Assistance Award from FDA

Guerbet, a pioneer in the field of contrast agents for medical imaging, has received a Drug Shortage Assistance Award from the U.S. Food and Drug Administration for its assistance in preventing or alleviating a drug shortage.

29 Sep 2014

New Drug Application News and Research

Impax announces submission of EMA Marketing Authorization Application for IPX066

Mylan announces U.S. launch of generic Loestrin 24 Fe

Glenmark gets final approval from FDA for Omeprazole DR Capsules ANDA

Avanir Pharmaceuticals to publish AVP-825 phase III study results in the journal 'Headache'

FDA recommens approval of Daiichi Sankyo's once-daily SAVAYSA for patients with NVAF

Neurocrine Biosciences' NBI-98854 drug gets breakthrough designation for tardive dyskinesia

Auxilium Pharmaceuticals reports total revenues of $109.6 million for Q3 2014

TWi Pharmaceuticals obtains final ANDA approval for Donepezil Hydrochloride Tablets USP, 23 mg

Vanda reports total revenues of $14.8 million for third quarter 2014

Regulus Therapeutics demonstrates human proof-of-concept with microRNA therapeutic

FDA accepts Eisai's sNDA for perampanel drug for treatment of PGTC seizures

Janssen announces submission of IMBRUVICA sNDA to FDA for WM treatment

Actavis seeks FDA approval to market generic version of Quillivant XR

Highland completes US$25 million offering of Class A Common Shares

Eisai, Helsinn Group announce FDA approval of AKYNZEO for prevention of CINV

Shire receives FDA guidance on regulatory path for investigational compound SHP 465

Isavuconazole demonstrates successful outcomes in treatment of mucormycosis

Par Pharmaceutical starts shipping generic version of Exforge

Bausch + Lomb’s sub-micron loteprednol etabonate ophthalmic gel meets primary endpoint

Guerbet wins Drug Shortage Assistance Award from FDA

Drug Discovery - Second Edition eBook

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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