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Onyx receives FDA Standard Review designation for carfilzomib NDA to treat RRMM

Onyx Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Standard Review designation to the New Drug Application (NDA) for carfilzomib for the potential treatment of patients with relapsed and refractory multiple myeloma.

12 Dec 2011

VIVUS announces results of Qnexa clinical study on cardiometabolic disease

VIVUS, Inc. today announced that results from the SEQUEL study were published in The American Journal of Clinical Nutrition, a peer-reviewed journal with broad, multidisciplinary readership.

9 Dec 2011

PDUFA goal date of NDA for Protalix's taliglucerase alfa extended

Protalix BioTherapeutics, Inc., announced today that it received notification from the U.S. Food and Drug Administration (FDA) that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date of the New Drug Application (NDA) for taliglucerase alfa to May 1, 2012, a three-month extension from the previous PDUFA date of February 1, 2012.

6 Dec 2011

FDA assigns CTIs' pixantrone NDA new PDUFA action date

Cell Therapeutics, Inc. today announced that the U.S. Food and Drug Administration's Division of Oncology Products 1 has notified CTI that CTI's October 2011 resubmitted New Drug Application is considered a complete, Class 2 response to the FDA's April 2010 complete response letter.

6 Dec 2011

CDER, Shire enter agreement for ProAmatine clinical trial to treat symptomatic orthostatic hypotension

Shire plc, the global specialty biopharmaceutical company, announces that it has reached an agreement with the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration to conduct additional clinical trials to confirm the clinical benefit of ProAmatine (midodrine HCl), a medicine approved in 1996 under Subpart H for the treatment of symptomatic orthostatic hypotension (SOH).

3 Dec 2011

FDA approves Mylan's Tranexamic Acid Injection ANDA

Mylan Inc. today announced that its business Mylan Institutional has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Tranexamic Acid Injection, 100 mg/mL, packaged in 1,000 mg/10 mL Single-dose Vials.

3 Dec 2011

Mylan's NDA for Atazanavir Sulfate and Ritonavir Tablets receives tentative FDA approval through PEPFAR

Mylan Inc. today announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration through the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Atazanavir Sulfate and Ritonavir Tablets, 300 mg/100 mg.

2 Dec 2011

Arbor files first NDA with U.S. FDA

Arbor Pharmaceuticals announced today that it has filed its first New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). The recently filed product has been granted an Orphan designation by the FDA which provides seven years of market exclusivity.

2 Dec 2011

Mylan confirms generic Generess Fe patent challenge

Mylan Inc. today confirmed that it and Famy Care Ltd. have been sued by Warner Chilcott Company LLP, in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Norethindrone and Ethinyl Estradiol Chewable Tablets, 0.8 mg/0.025 mg and Ferrous Fumarate Chewable Tablets. This product is the generic version of Generess Fe, a 28-day regimen indicated for use by women to prevent pregnancy.

2 Dec 2011

FDA approves Watson's ANDA for generic Yaz oral contraceptive

Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Vestura (3 mg drospirenone and 0.02 mg ethinyl estradiol), a generic version of Bayer's Yaz oral contraceptive product.

29 Nov 2011

FDA assigns priority-review designation for ELIQUIS NDA for stroke prevention in atrial fibrillation

Bristol-Myers Squibb Company and Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for ELIQUIS® (apixaban), an investigational compound for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

29 Nov 2011

FDA approves Mylan's generic Dexrazoxane for Injection ANDA

Mylan Inc. today announced that its business Mylan Institutional has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Dexrazoxane for Injection, packaged in 250 mg and 500 mg Single-use Vials. This product is the generic version of Pharmacia & Upjohn's Zinecard® for Injection, a chemoprotective agent.

28 Nov 2011

FDA grants Perrigo final approval for Guaifenesin Extended-Release Tablets ANDA

Perrigo Company today announced that it received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Guaifenesin Extended-Release Tablets, 600 mg.

28 Nov 2011

Exelixis and NCI's CTEP enter CRADA to further evaluate cabozantinib

Exelixis, Inc. today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute's Cancer Therapy Evaluation Program (CTEP) for further evaluation of cabozantinib, Exelixis' lead compound, in a variety of solid tumors.

28 Nov 2011

Takeda submits alogliptin plus metformin NDA to FDA for treatment of type 2 diabetes

Takeda Pharmaceutical Company Limited (Takeda) announced today that its wholly-owned subsidiary Takeda Global Research & Development Center, Inc., U.S., submitted a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for the fixed-dose combination therapy alogliptin/metformin, which combines alogliptin with metformin in a single tablet.

24 Nov 2011

FDA accepts Otsuka's aripiprazole depot formulation NDA for review

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announced today that the U.S. Food and Drug Administration has determined that a new drug application (NDA) for Otsuka's investigational once-monthly aripiprazole depot formulation for the indication of maintenance treatment of schizophrenia in adults is sufficiently complete to permit a substantive review.

22 Nov 2011

Impax initiates patent challenge related to Fentora

Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patents listed in the Orange Book in connection with Fentora® (fentanyl buccal tablets, 100 mcg, 200 mcg, 400 mcg, 600 mcg and 800 mcg).

21 Nov 2011

Mylan settles Vivelle-Dot patent litigation lawsuit with Novartis

Mylan Inc. today announced that it has settled a patent litigation lawsuit with Novartis Pharmaceuticals Corporation related to Vivelle-Dot® (Estradiol Transdermal System USP, Twice-Weekly, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day and 0.075 mg/day and 0.1 mg/day).

21 Nov 2011

Tonix to initiate TNX-102 PK and BA study for fibromyalgia

Tonix Pharmaceuticals Holding Corp., a specialty pharmaceutical company developing therapies for challenging disorders of the central nervous system, including fibromyalgia syndrome and post-traumatic stress disorder, will initiate a comparative pharmacokinetic and bioavailability study of TNX-102, a novel dosage oral formulation of cyclobenzaprine for the treatment of FM, following the U.S. Food and Drug Administration clearance of the Company's initial Investigational New Drug Application.

18 Nov 2011

Additional results from BioSante's LibiGel pK study on HSDD

BioSante Pharmaceuticals, Inc., today announced additional results from its principal LibiGel (testosterone gel) pharmacokinetic (pK) study. Top line data from this study were announced on September 12, 2011.

16 Nov 2011