New Drug Application News and Research

RSS

FDA grants Mylan tentative approval for Atorvastatin Calcium ANDA

Mylan Inc. today announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Atorvastatin Calcium Tablets, 10 mg, 20 mg, 40 mg and 80 mg.

3 Feb 2012

Takeda, SPI announce that lubiprostone phase 3 trial on OBD meets primary endpoint

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A., Inc. announced today that lubiprostone met the primary endpoint in a phase 3 clinical trial for the treatment of opioid-induced bowel dysfunction (OBD) in patients with chronic, non-cancer pain, excluding those taking methadone.

2 Feb 2012

FDA EMDAC to discuss Arena's lorcaserin NDA resubmission in second quarter

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that the US Food and Drug Administration (FDA) has notified Arena that an Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss the lorcaserin New Drug Application (NDA) resubmission will be held in the second quarter of 2012. Confirmation and details of the meeting will be published in the Federal Register.

2 Feb 2012

FDA approves Lannett's supplemental ANDA for Phentermine HCl to treat obesity

Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its supplemental Abbreviated New Drug Application (ANDA) for Phentermine HCl Capsules, 15 mg.

1 Feb 2012

Takeda returns POSIDUR development and commercialization rights to DURECT

DURECT Corporation today reported that Takeda has given notice that it is returning its development and commercialization rights to POSIDUR in Europe and their other licensed territories.

31 Jan 2012

FDA approves Lannett's ANDA for Hydrochlorothiazide Capsules, 12.5 mg

Lannett Company, Inc. today announced it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Hydrochlorothiazide Capsules, 12.5 mg.

30 Jan 2012

Cell Therapeutics voluntarily withdraws Pixuvri NDA for NHL

Cell Therapeutics, Inc. announced today that it has voluntarily withdrawn its New Drug Application for Pixuvri (pixantrone) for the treatment of relapsed or refractory aggressive non-Hodgkin's lymphoma in patients who failed two or more lines of prior therapy.

30 Jan 2012

Gilead commences GS-7340 Phase 2 trial in HIV

Gilead Sciences, Inc. today announced the initiation of a Phase 2 clinical trial evaluating GS-7340 for the treatment of HIV-1 infection in treatment-naïve adults. GS-7340 is a novel prodrug of tenofovir, the active agent in Viread.

24 Jan 2012

Perrigo files ANDA and confirms Astepro Nasal Spray patent challenge

Perrigo Company announced that it has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) for azelastine hydrochloride nasal spray (0.15%) and has notified Meda Pharmaceuticals, Inc., the owner of the New Drug Application (NDA) of its filing. The ANDA filing involved contributions from both Perrigo and Impax Laboratories, Inc., who will share costs and benefits of this project.

24 Jan 2012

Takeda receives FDA approval for VELCADE sNDA to treat MM

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE(bortezomib), which updates the label to include the subcutaneous method of administration in all approved indications: multiple myeloma and mantle cell lymphoma after at least one prior therapy.

24 Jan 2012

Ikaria receives FDA orphan drug designation for use of iNO in PAH

Ikaria, Inc., a critical care company focused on developing and commercializing innovative therapies for critically ill patients, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the use of inhaled nitric oxide (iNO) with the INOpulse DS drug-delivery system as a combination product for pulmonary arterial hypertension.

23 Jan 2012

EMA CHMP may issue an opinion on CTI's Pixuvri MAA in mid-Feb.

Cell Therapeutics, Inc. ("CTI") announced today that, following discussions with the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP"), the CHMP may issue an opinion on CTI's Marketing Authorization Application ("MAA") for Pixuvri in mid-February.

20 Jan 2012

FDA issues complete response letter to Bristol-Myers Squibb and AstraZeneca's dapagliflozin

Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for investigational compound dapagliflozin for the treatment of type 2 diabetes in adults.

19 Jan 2012

Gilead Sciences receives FDA approval for Viread to treat pediatric HIV infection

Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Viread in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients ages 2-12.

19 Jan 2012

EMA grants Orphan Drug Designation to Ceptaris' chlormethine gel for treatment of CTCL

Ceptaris Therapeutics, Inc., a privately held specialty pharmaceutical company, announced today that the European Medicines Agency (EMA) has granted Orphan Drug Designation to Ceptaris' investigational drug, chlormethine gel, for the treatment of Cutaneous T-Cell Lymphoma.

18 Jan 2012

Mylan confirms Actoplus Met XR patent challenge

Mylan Inc. today confirmed that the company has been sued by Takeda Pharmaceutical Company, Watson Pharmaceuticals and Andrx Labs in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Pioglitazone Hydrochloride and Extended-release Metformin Hydrochloride tablets, 15 mg/1000 mg and 30 mg/1000 mg.

9 Jan 2012

Alnylam files CTA with the U.K. MHRA to initiate ALN-TTR02 Phase I trial in ATTR

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has filed a Clinical Trial Application (CTA) with the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase I clinical trial with ALN-TTR02, an RNAi therapeutic targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis.

7 Jan 2012

Endo, BDSI partner to develop and commercialize BEMA Buprenorphine for chronic pain

BioDelivery Sciences International, Inc. today announced the signing of a worldwide license and development agreement with Endo Pharmaceuticals for the exclusive rights to develop and commercialize BEMA Buprenorphine for the treatment of chronic pain.

6 Jan 2012

Positive preliminary results from Alnylam's Phase I ALN-PCS trial on severe hypercholesterolemia

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today the achievement of positive preliminary results from its ongoing clinical trial of ALN-PCS, an RNAi therapeutic targeting PCSK9 for the treatment of severe hypercholesterolemia.

5 Jan 2012

Arrowhead receives FDA IND approval for Adipotide obesity drug

Arrowhead Research Corporation, a nanomedicine company with development programs in oncology and obesity, today announced that the Investigational New Drug Application (IND) for its first obesity drug candidate, Adipotide, was accepted by the U.S. Food and Drug Administration allowing the initiation of a clinical trial to test the safety of the compound.

5 Jan 2012

New Drug Application News and Research

FDA grants Mylan tentative approval for Atorvastatin Calcium ANDA

Takeda, SPI announce that lubiprostone phase 3 trial on OBD meets primary endpoint

FDA EMDAC to discuss Arena's lorcaserin NDA resubmission in second quarter

FDA approves Lannett's supplemental ANDA for Phentermine HCl to treat obesity

Takeda returns POSIDUR development and commercialization rights to DURECT

FDA approves Lannett's ANDA for Hydrochlorothiazide Capsules, 12.5 mg

Cell Therapeutics voluntarily withdraws Pixuvri NDA for NHL

Gilead commences GS-7340 Phase 2 trial in HIV

Perrigo files ANDA and confirms Astepro Nasal Spray patent challenge

Takeda receives FDA approval for VELCADE sNDA to treat MM

Ikaria receives FDA orphan drug designation for use of iNO in PAH

EMA CHMP may issue an opinion on CTI's Pixuvri MAA in mid-Feb.

FDA issues complete response letter to Bristol-Myers Squibb and AstraZeneca's dapagliflozin

Gilead Sciences receives FDA approval for Viread to treat pediatric HIV infection

EMA grants Orphan Drug Designation to Ceptaris' chlormethine gel for treatment of CTCL

Mylan confirms Actoplus Met XR patent challenge

Alnylam files CTA with the U.K. MHRA to initiate ALN-TTR02 Phase I trial in ATTR

Endo, BDSI partner to develop and commercialize BEMA Buprenorphine for chronic pain

Positive preliminary results from Alnylam's Phase I ALN-PCS trial on severe hypercholesterolemia

Arrowhead receives FDA IND approval for Adipotide obesity drug

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