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Experimental drug fampridine improves mobility for some MS patients

In MS, the body's immune system attacks myelin, a fatty tissue that wraps and insultates nerve fibers, disrupting the transmission of signals in the central nervous system.

1 Mar 2009

Schering-Plough submits response to FDA for SAPHRIS (asenapine) in the acute treatment of schizophrenia and bipolar I disorder

Schering-Plough Corporation has announced that it has responded to the U.S. Food and Drug Administration (FDA) complete response letter for SAPHRIS (asenapine) sublingual tablets, which was received in January 2009.

22 Feb 2009

Arpida receives FDA complete response letter for Iclaprim

Arpida Ltd. has announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for intravenous iclaprim for the treatment of complicated skin and skin structure infections (cSSSI).

19 Jan 2009

Roxane Labs launches Levetiracetam tablets and oral solution

Roxane Laboratories, Inc. has announced the approval of their Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets, 250mg, 500mg, 750mg, 1000mg, and Oral Solution 100mg/mL.

19 Jan 2009

Eli Lilly to pay $1.415 billion for off-label promotion of Zyprexa

American pharmaceutical giant Eli Lilly and Company today agreed to plead guilty and pay $1.415 billion for promoting its drug Zyprexa for uses not approved by the Food and Drug Administration (FDA), the Department of Justice announced today.

19 Jan 2009

FDA issues complete response letter for SAPHRIS (asenapine) sublingual tablets in acute treatment of schizophrenia and bipolar disorder

Schering-Plough Corporation has announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for SAPHRIS (asenapine) sublingual tablets in the acute treatment of schizophrenia in adults and in the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy.

15 Jan 2009

GSK and XenoPort resubmit NDA for Solzira in restless legs syndrome

GlaxoSmithKline and XenoPort, Inc. announced today that GSK has resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting approval of Solzira(TM) (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

12 Jan 2009

Lilly receives complete response letter for Olanzapine LAI for treatment of schizophrenia

Eli Lilly and Company has announced that it received a complete response letter from the U.S. Food and Drug Administration (FDA) for olanzapine long-acting injection (LAI) for acute and maintenance treatment of schizophrenia in adults.

7 Jan 2009

Final FDA approval for generic version of antiretroviral Zerit capsules

Mylan Inc. has announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.5% controlling interest, received final approval from the U.S. Food and Drug Administration (FDA) on December 29, for its Abbreviated New Drug Application (ANDA) for Stavudine Capsules USP, 15 mg, 20 mg, 30 mg and 40 mg.

1 Jan 2009

Watson Pharmaceuticals receives FDA approval for generic Mircette

Watson Pharmaceuticals, Inc. has received final approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP, 0.15 mg / 0.02 mg.

30 Dec 2008

Salix Pharmaceuticals receives FDA response for Balsalazide tablet

Salix Pharmaceuticals, Ltd. has announced that the Company has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for balsalazide tablet studied as a treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older.

30 Dec 2008

AstraZeneca submits sNDA for NEXIUM (esomeprazole magnesium)

AstraZeneca has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for NEXIUM(R) (esomeprazole magnesium) to seek approval for the short-term (up to 6 weeks) treatment of gastroesophageal reflux disease (GERD) in pediatric patients ages 0 to 1 year old.

21 Dec 2008

Neuralstem files IND for amyotrophic lateral sclerosis stem cell trial

Neuralstem, Inc. announced this morning that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a clinical trial to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease).

18 Dec 2008

Watson Pharmaceuticals receives FDA approval for generic Razadyne ER capsules

Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for galantamine hydrobromide extended-release capsules, eq. to 8 mg, 16 mg and 24 mg (galantamine base).

17 Dec 2008

Bolder BioTechnology awarded NIH grant to continue development of growth hormone product

Bolder BioTechnology, Inc. today announced that it has been awarded a $1.9 million Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) of The National Institutes of Health (NIH).

16 Dec 2008

DNA vaccine for SARS achieves neutralizing responses in first U.S. human trial

Vical Incorporated (NASDAQ:VICL) today announced that results from a Phase I clinical trial of a DNA vaccine for severe acute respiratory syndrome (SARS), conducted by the National Institutes of Health (NIH) and published in the November 25 issue of Vaccine(1), demonstrated that the vaccine was well-tolerated, and induced neutralizing antibody responses in 80% of the vaccinees and T-cell immune responses in all vaccinees.

10 Dec 2008

RHEI Pharmaceuticals starts final trial of Tibozole in China

RHEI Pharmaceuticals, Inc. has announced that the final clinical trial for Tibozole, a locally active antifungal with low dose miconazole in a patented mucoadhesive system, has been initiated in China.

8 Dec 2008

Allos Therapeutics announces results from phase 2 trial of Pralatrexate in peripheral T-cell lymphoma

Allos Therapeutics, Inc. has announced preliminary top line results from PROPEL, the Company's pivotal Phase 2 trial of pralatrexate (PDX) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), at the 50th Annual Meeting of the American Society of Hematology (abstract 261).

8 Dec 2008

Trial shows Elitek significantly reduces plasma uric acid levels versus Allopurinol in adults with hematologic cancers at risk for tumor Lysis syndrome

Sanofi-aventis has announced results of a randomized phase III study presented at the 50th Annual Meeting of the American Society of Hematology.

7 Dec 2008

New data demonstrates efficacy and tolerability of Carisbamate as an adjunctive therapy for partial onset seizures

Phase III data on carisbamate, an investigational compound recently filed with the FDA for the adjunctive treatment of partial onset seizures (POS) in patients 16 years of age and older, was presented during the poster sessions of the 32nd Annual Meeting of the American Epilepsy Society.

7 Dec 2008