New Drug Application News and Research

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Actavis seeks FDA ANDA approval for generic Zubsolv, confirms patent challenge

Actavis plc today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablets, Eq, 1.4 mg/0.36 mg and 5.7 mg/1.4 mg Base. Actavis' ANDA product is a generic version of Orexo's Zubsolv, which is a partial opioid agonist indicated for the maintenance treatment of opioid dependence.

30 Jun 2014

Forest Laboratories reports positive results from three Phase III trials of vilazodone for GAD treatment

Forest Laboratories, Inc. today announced positive topline results from three Phase III trials evaluating the efficacy, safety and tolerability of vilazodone in adult patients with generalized anxiety disorder (GAD).

24 Jun 2014

Cubist Pharmaceuticals' SIVEXTRO receives FDA approval for treatment of ABSSSI

Cubist Pharmaceuticals, Inc. announced today the U.S. Food and Drug Administration approved SIVEXTRO (tedizolid phosphate) for the treatment of adult acute bacterial skin and skin structure infections (ABSSSI).

21 Jun 2014

IGI Laboratories submits third ANDA in 2014 to FDA

IGI Laboratories, Inc., a New Jersey based generic topical pharmaceutical company, today announced it has submitted its third abbreviated new drug application (ANDA) in 2014 to the U.S. Food and Drug Administration, which brings the Company's total number of ANDA submissions to sixteen, with fourteen now pending at the FDA.

18 Jun 2014

Alkermes reports data from aripiprazole lauroxil phase 3 clinical trial for treatment of schizophrenia

Alkermes plc today announced the presentation of data from its phase 3 clinical trial of aripiprazole lauroxil, an investigational drug candidate in development for schizophrenia, at the American Society of Clinical Psychopharmacology Annual Meeting in Hollywood, Fla.

18 Jun 2014

Novogen, CanTx believe Intra-Peritoneal Trx-1 could be utilized as first-line therapy for ovarian cancer

Australian oncology drug development company Novogen Limited and CanTx Inc., its joint venture with Yale University, today announced the success of proof-of-concept pre-clinical studies confirming the potency of experimental drug, Trx-1, in the treatment of primary ovarian cancer when delivered into the peritoneal cavity.

18 Jun 2014

FDA accepts Symplmed's Prestalia NDA for hypertension treatment

Symplmed announced today that the U.S. Food and Drug Administration has accepted for review its New Drug Application (NDA) for investigational drug Prestalia, the first single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate for the treatment of hypertension in the U.S. Symplmed filed the application under section 505(b)(2) consistent with FDA's guidance.

18 Jun 2014

BIPI, Lilly announce resubmission of empagliflozin NDA to FDA for treatment of type 2 diabetes

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company today announced the resubmission of a New Drug Application (NDA) for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin for the treatment of adults with type 2 diabetes (T2D) to the U.S. Food and Drug Administration (FDA).

17 Jun 2014

Breckenridge announces launch of Duloxetine Delayed-release Capsules

Breckenridge Pharmaceutical, Inc. announced today the immediate launch of Duloxetine Delayed-release Capsules.

12 Jun 2014

Mylan launches Risedronate Sodium Tablets USP, 150 mg

Mylan Inc. today announced that it has launched Risedronate Sodium Tablets USP, 150 mg, the generic version of Warner Chilcott's Actonel Tablets. Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

11 Jun 2014

Alkermes initiates FORWARD-3 and FORWARD-4 efficacy studies in pivotal clinical program for ALKS 5461

Alkermes plc today announced the initiation of FORWARD-3 and FORWARD-4, two of the three planned phase 3 core efficacy studies in the pivotal clinical program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD).

10 Jun 2014

Alnylam announces new pre-clinical results with DC for ALN-CC5 to treat complement-mediated diseases

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today new pre-clinical results with its Development Candidate (DC) for ALN-CC5, a subcutaneously administered investigational RNAi therapeutic targeting complement component C5 in development for the treatment of complement-mediated diseases.

10 Jun 2014

FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

Pharmacyclics, Inc. today announced that the U.S. Food and Drug Administration has accepted for filing its supplemental New Drug Application (sNDA) to support the review of IMBRUVICA (ibrutinib) in the treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have received at least one prior therapy for a full approval.

9 Jun 2014

BioDelivery Sciences receives approval of NDA for BUNAVAIL from FDA

BioDelivery Sciences International, Inc. received approval of the New Drug Application (NDA) for BUNAVAIL™ (buprenorphine and naloxone) buccal film (CIII) from the U.S. Food and Drug Administration (FDA).

9 Jun 2014

Mylan launches generic version of Bristol-Myers Squibb's Paraplatin Injection

Mylan Inc. today announced that it has launched Carboplatin Injection, 50 mg/5 ml, in multi-dose vials, which is the generic version of Bristol-Myers Squibb's Paraplatin® Injection.

9 Jun 2014

Cubist Pharmaceuticals publishes positive results from Phase 3 clinical trial of SIVEXTRO

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that The Lancet Infectious Diseases published online the positive results from ESTABLISH-2, a pivotal Phase 3 clinical trial of the investigational antibiotic SIVEXTRO™ (tedizolid phosphate), which is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and complicated skin and soft tissue infections (cSSTI).

9 Jun 2014

Valeant Pharmaceuticals receives approval from FDA for treatment of onychomycosis

Valeant Pharmaceuticals International, Inc. today announced that that its wholly owned subsidiary, Valeant Pharmaceuticals North America LLC, received notice that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Jublia® (efinaconazole 10% topical solution), the first topical triazole approved for the treatment of onychomycosis of the toenails.

9 Jun 2014

New drug shows promising results in patients with advanced pancreatic cancer

A clinical trial conducted by researchers at the Virginia G. Piper Cancer Center Clinical Trials, a partnership between Scottsdale Healthcare and the Translational Genomics Research Institute, showed that a new drug called MM-398, given in combination with 5-flourouracil (5FU) and leucovorin, produced a significant overall survival rate in patients with advanced, previously-treated pancreatic cancer.

6 Jun 2014

Naloxegol holds hope for opioid-induced constipation

Pain medicines often lead to constipation for patients seeking long-term pain relief, but an investigational once-daily drug may help, according to study led by the University of Michigan Health System.

5 Jun 2014

NEJM publishes results from SOLO I Phase 3 clinical trial of ORBACTIV for ABSSSI

The Medicines Company today announced the publication of the results from the SOLO I Phase 3 clinical trial of ORBACTIV (oritavancin), an investigational intravenous antibiotic treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI), in the New England Journal of Medicine.

5 Jun 2014

New Drug Application News and Research

Actavis seeks FDA ANDA approval for generic Zubsolv, confirms patent challenge

Forest Laboratories reports positive results from three Phase III trials of vilazodone for GAD treatment

Cubist Pharmaceuticals' SIVEXTRO receives FDA approval for treatment of ABSSSI

IGI Laboratories submits third ANDA in 2014 to FDA

Alkermes reports data from aripiprazole lauroxil phase 3 clinical trial for treatment of schizophrenia

Novogen, CanTx believe Intra-Peritoneal Trx-1 could be utilized as first-line therapy for ovarian cancer

FDA accepts Symplmed's Prestalia NDA for hypertension treatment

BIPI, Lilly announce resubmission of empagliflozin NDA to FDA for treatment of type 2 diabetes

Breckenridge announces launch of Duloxetine Delayed-release Capsules

Mylan launches Risedronate Sodium Tablets USP, 150 mg

Alkermes initiates FORWARD-3 and FORWARD-4 efficacy studies in pivotal clinical program for ALKS 5461

Alnylam announces new pre-clinical results with DC for ALN-CC5 to treat complement-mediated diseases

FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

BioDelivery Sciences receives approval of NDA for BUNAVAIL from FDA

Mylan launches generic version of Bristol-Myers Squibb's Paraplatin Injection

Cubist Pharmaceuticals publishes positive results from Phase 3 clinical trial of SIVEXTRO

Valeant Pharmaceuticals receives approval from FDA for treatment of onychomycosis

New drug shows promising results in patients with advanced pancreatic cancer

Naloxegol holds hope for opioid-induced constipation

NEJM publishes results from SOLO I Phase 3 clinical trial of ORBACTIV for ABSSSI

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