New Drug Application News and Research

RSS

FDA approves Cephalon's REMS for FENTORA, ACTIQ

Cephalon, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved the Risk Evaluation and Mitigation Strategy (REMS) for FENTORA and ACTIQ.

22 Jul 2011

FDA approves Boca Pharmacal's Hydrocodone Bitartrate and Acetaminophen Oral Solution ANDA

Boca Pharmacal, Inc., today announced that it has received approval from the FDA of its Abbreviated New Drug Application (ANDA) for Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5mg / 325mg per 5mL, the generic version of Hycet Oral Solution distributed by FSC Laboratories, Inc.

22 Jul 2011

Investigational compound dapagliflozin receives negative recommendation from FDA Advisory Committee

Bristol-Myers Squibb Company and AstraZeneca today reported the outcome of the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee meeting on the New Drug Application for the investigational compound dapagliflozin.

20 Jul 2011

Millennium submits VELCADE sNDA to FDA to add OS data for previously untreated multiple myeloma

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced the submission of a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration for VELCADE® (bortezomib) for injection to add overall survival data after a five-year follow up to the product label.

20 Jul 2011

FDA approves Lannett's Diethylproprion HCl Tablets ANDA for anti-obesity treatment

Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) of Diethylproprion HCl Tablets, 25 mg. Diethylproprion HCl Tablets, 25 mg, is therapeutically equivalent to the reference listed drug, Tenuate Tablets, 25 mg, of Watson Pharmaceuticals.

19 Jul 2011

QRxPharma seeks NDA approval for MoxDuo IR

QRxPharma Limited announced today initiation of the New Drug Application (NDA) approval process for MoxDuo IR with the United States Food and Drug Administration (FDA). This NDA submission sets the stage for the regulatory approval process for MoxDuo IR for the treatment of moderate to severe acute pain, a $2.5 billion segment of the $8 billion spent annually on prescription opioids in the US.

18 Jul 2011

Transcept decreases workforce following FDA news on Intermezzo NDA

Transcept Pharmaceuticals, Inc. announced today plans to reduce operating expenses by eliminating approximately 45% of its workforce following notification from the U.S. Food and Drug Administration (FDA) that the resubmitted New Drug Application (NDA) for Intermezzo, the company's lead product candidate, cannot be approved in its present form.

16 Jul 2011

Transcept receives FDA Complete Response Letter for Intermezzo NDA

Transcept Pharmaceuticals, Inc. announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding the resubmitted New Drug Application (NDA) for Intermezzo.

15 Jul 2011

Michael J. Fox Foundation awards Impax $400,000 grant for research of IPX066 for Parkinson’s disease

Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc., has been awarded funding of up to $400,000 by The Michael J. Fox Foundation for ongoing clinical research of the Company's investigational carbidopa-levodopa extended release (CD-LD ER) product IPX066, which is intended to treat the motor symptoms of Parkinson's disease (PD).

14 Jul 2011

Eisai's DACOGEN sNDA for acute myeloid leukemia accepted by FDA for review

SuperGen, Inc., a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, announced that Eisai Inc. today released information that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) seeking approval of DACOGEN (decitabine) for injection in the treatment of acute myeloid leukemia.

14 Jul 2011

Chimerix initiates CMX001 Phase 2 study for prevention of adenovirus disease following HSCT

Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, today announced that patient dosing has begun in the AdV HALT Trial (A Randomized, Placebo-Controlled, Multi-site Phase 2 Study Evaluating the Safety and Efficacy of Preemptive Treatment with CMX001 for the Prevention of Adenovirus Disease Following Hematopoietic Stem Cell Transplantation [HSCT]).

14 Jul 2011

FDA accepts Eisai's DACOGEN sNDA for review to treat acute myeloid leukemia

Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) seeking approval of DACOGEN (decitabine) for injection in the treatment of acute myeloid leukemia.

13 Jul 2011

Ivermectin cream demonstrates activity against head lice eggs

In a study sponsored by Topaz Pharmaceuticals Inc., a privately held specialty pharmaceutical company, scientists from the University of Massachusetts, Amherst presented data showing that a 0.5% ivermectin (IVM) cream formulation was active against lice eggs from permethrin resistant head lice.

11 Jul 2011

FDA-approved Zuplenz oral soluble film now available for licensing to new commercial partners

MonoSol Rx, a specialty pharmaceutical company and the developers of the PharmFilm technology platform, in collaboration with APR Applied Pharma Research s.a. of Switzerland, announced today that its FDA-approved anti-emetic Zuplenz (Ondansetron) oral soluble film is available for licensing to new commercial partners.

11 Jul 2011

Alnylam seeks CTA clearance to initiate ALN-PCS Phase I clinical trial for severe hypercholesterolemia

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has filed a Clinical Trial Application (CTA) with the Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase I clinical trial with ALN-PCS, an RNAi therapeutic for the treatment of severe hypercholesterolemia.

11 Jul 2011

Antares, Watson enter license deal to commercialize Anturol in the U.S. and Canada

Watson Pharmaceuticals, Inc. and Antares Pharma, Inc. today announced an exclusive licensing agreement for Watson to commercialize Antares' topical oxybutynin gel product in the U.S. and Canada.

11 Jul 2011

Shire files lawsuit against Watson over generic Vyvanse

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market lisdexamfetamine dimesylate capsules. Watson's lisdexamfetamine dimesylate capsules are a generic version of Shire LLC's Vyvanse®.

8 Jul 2011

Exenatide tQT clinical trial meets pre-specified primary endpoint

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced results from a thorough QT (tQT) study that assessed the potential of exenatide to increase the QT interval across a wide range of plasma concentrations.

8 Jul 2011

Enrollment commences in InterMune's Esbriet Phase 3 study for IPF

InterMune today announced that patient enrollment has begun in ASCEND, a new Phase 3 study of pirfenidone for patients who suffer from idiopathic pulmonary fibrosis.

8 Jul 2011

New clot busting drug approved in UK

The National Institute for Clinical Excellence (Nice), UK, has approved a new drug which one study has suggested could reduce the risk of death from a second heart attack by 20 per cent. The drug is manufactured by AstraZeneca as Brilique. It works by maintaining cardiac blood flow and stopping new blood clots from forming.

1 Jul 2011

New Drug Application News and Research

FDA approves Cephalon's REMS for FENTORA, ACTIQ

FDA approves Boca Pharmacal's Hydrocodone Bitartrate and Acetaminophen Oral Solution ANDA

Investigational compound dapagliflozin receives negative recommendation from FDA Advisory Committee

Millennium submits VELCADE sNDA to FDA to add OS data for previously untreated multiple myeloma

FDA approves Lannett's Diethylproprion HCl Tablets ANDA for anti-obesity treatment

QRxPharma seeks NDA approval for MoxDuo IR

Transcept decreases workforce following FDA news on Intermezzo NDA

Transcept receives FDA Complete Response Letter for Intermezzo NDA

Michael J. Fox Foundation awards Impax $400,000 grant for research of IPX066 for Parkinson’s disease

Eisai's DACOGEN sNDA for acute myeloid leukemia accepted by FDA for review

Chimerix initiates CMX001 Phase 2 study for prevention of adenovirus disease following HSCT

FDA accepts Eisai's DACOGEN sNDA for review to treat acute myeloid leukemia

Ivermectin cream demonstrates activity against head lice eggs

FDA-approved Zuplenz oral soluble film now available for licensing to new commercial partners

Alnylam seeks CTA clearance to initiate ALN-PCS Phase I clinical trial for severe hypercholesterolemia

Antares, Watson enter license deal to commercialize Anturol in the U.S. and Canada

Shire files lawsuit against Watson over generic Vyvanse

Exenatide tQT clinical trial meets pre-specified primary endpoint

Enrollment commences in InterMune's Esbriet Phase 3 study for IPF

New clot busting drug approved in UK

Advancing Intracellular Delivery with LumiPore®

How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

The role of UV-Vis in biopharma QC

Latest News