New Drug Application News and Research RSS Feed - New Drug Application News and Research

InnoPharma receives FDA approval for generic DACOGEN

InnoPharma receives FDA approval for generic DACOGEN

InnoPharma, Inc. today announced the approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for decitabine for injection, a generic version of Eisai Inc.'s DACOGEN. [More]
FDA accepts Mylan's ANDA filing for generic Copaxone 40 mg/mL

FDA accepts Mylan's ANDA filing for generic Copaxone 40 mg/mL

Mylan Inc. today announced that its abbreviated new drug application (ANDA) for a three times per week Glatiramer Acetate Injection 40 mg/mL has been accepted for filing by the U.S. Food and Drug Administration. [More]
Amgen's ivabradine receives FDA priority review designation for treatment of chronic heart failure

Amgen's ivabradine receives FDA priority review designation for treatment of chronic heart failure

Amgen today announced the U.S. Food and Drug Administration has granted priority review designation for ivabradine for the treatment of chronic heart failure (HF). [More]
TWi Pharmaceuticals obtains final approval from FDA for megestrol acetate 125mg/ml oral suspension

TWi Pharmaceuticals obtains final approval from FDA for megestrol acetate 125mg/ml oral suspension

TWi Pharmaceuticals, Inc. today announced that it has received final approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for megestrol acetate 125mg/ml oral suspension, the generic equivalent to Par Pharmaceutical's Megace ES. [More]
Actavis files ANDA for generic version of Neupro

Actavis files ANDA for generic version of Neupro

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 Rotigotine Extended-release Transdermal Film, 1 mg/24 hr, 2mg/24 hr, 3 mg/24hr, 4 mg/24 hr, 6mg/24hr, and 8 mg/24 hr. [More]

Mylan launches Potassium Chloride Extended-release Tablets

Mylan Inc. today announced that it has launched Potassium Chloride Extended-release Tablets USP, 8 mEq (600 mg) and 10 mEq (750 mg), which is the generic version of Upsher-Smith's Klor-Con. [More]
KalVista begins Phase I trial of novel plasma kallikrein inhibitor for treatment of DME

KalVista begins Phase I trial of novel plasma kallikrein inhibitor for treatment of DME

KalVista Pharmaceuticals, an ophthalmology company with a focus on diabetic macular edema (DME), today announces that it has begun a Phase I, First in Human, trial of its novel plasma kallikrein inhibitor, KVD001, for the treatment of DME. [More]
Lilly and Boehringer Ingelheim's Basaglar (insulin glargine injection) gets FDA's tentative approval

Lilly and Boehringer Ingelheim's Basaglar (insulin glargine injection) gets FDA's tentative approval

The U.S. Food and Drug Administration today granted tentative approval for Basaglar (insulin glargine injection), which is indicated to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type 1 diabetes. [More]
Tarsa obtains $10 million senior credit facility to support NDA submission for Ostora tablet

Tarsa obtains $10 million senior credit facility to support NDA submission for Ostora tablet

Tarsa Therapeutics, Inc. today announced that it has secured a $10 million senior credit facility from Oxford Finance LLC and Square 1 Bank. The company intends to use the proceeds to support its plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration for its Ostora tablet for the treatment of postmenopausal osteoporosis, currently targeted for early 2015. [More]

SCILEX completes patient enrollment to study Ztlido for treatment of postherpetic neuralgia

SCILEX Pharmaceuticals, Inc., a company engaged in the development and commercialization of late-stage pharmaceutical products focused on the treatment of pain, announced today that it has completed patient enrollment for the dermal safety studies and the pivotal pharmacokinetic study related to its investigational product Ztlido (lidocaine patch 1.8%), a next-generation branded lidocaine patch for the treatment of postherpetic neuralgia, also referred to as "after-shingles pain." [More]
Mylan announces launch of Capecitabine Tablets USP, 150 mg and 500 mg

Mylan announces launch of Capecitabine Tablets USP, 150 mg and 500 mg

Mylan Inc. today announced that it has launched Capecitabine Tablets USP, 150 mg and 500 mg, the generic version of Genentech's Xeloda Tablets. Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for this product, which is indicated as monotherapy, adjuvant therapy and combination therapy for certain types of breast, colon and colorectal cancers. [More]
Aeterna Zentaris signs strategic co-promotion services agreement with ASCEND

Aeterna Zentaris signs strategic co-promotion services agreement with ASCEND

Aeterna Zentaris Inc. today announced a strategic co-promotion services agreement with ASCEND Therapeutics US, LLC. [More]
Endo International revenues increase $719M to 1% in Q2 2014

Endo International revenues increase $719M to 1% in Q2 2014

Endo International plc today reported second quarter 2014 revenues of $719 million, an increase of 1 percent compared to second quarter 2013 revenues of $712 million. [More]
Envarsus gets marketing authorization from EC for treatment of kidney and liver transplant patients

Envarsus gets marketing authorization from EC for treatment of kidney and liver transplant patients

Veloxis Pharmaceuticals A/S and Chiesi Farmaceutici S.p.A. today announced that the European Commission (EC) has granted marketing authorization for Envarsus for the prevention of organ rejection in adult kidney and liver transplant patients in the European Union. [More]
FDA issues Complete Response Letter for AcelRx's Zalviso NDA

FDA issues Complete Response Letter for AcelRx's Zalviso NDA

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Company's new drug application (NDA) for Zalviso (sufentanil sublingual tablet system). [More]
Galmed reports net loss of $3.9 million for six months ended June 30, 2014

Galmed reports net loss of $3.9 million for six months ended June 30, 2014

Galmed Pharmaceuticals Ltd., a clinical-stage biopharmaceutical company focused on the development and commercialization of a once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones, today announced financial results for the period ended June 30, 2014. [More]
EMA recommends full marketing approval for IMBRUVICA in the European Union

EMA recommends full marketing approval for IMBRUVICA in the European Union

Pharmacyclics, Inc. today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending the granting of full marketing approval for IMBRUVICA (ibrutinib) in the European Union. [More]
Shire, ArmaGen partner to develop AGT-182 drug for treatment of Hunter syndrome

Shire, ArmaGen partner to develop AGT-182 drug for treatment of Hunter syndrome

Shire plc, the global specialty biopharmaceutical company, and ArmaGen, a US privately held biotechnology company, today announced a worldwide licensing and collaboration agreement for AGT-182, an investigational enzyme replacement therapy (ERT) for the potential treatment of both the central nervous system (CNS) and somatic manifestations in patients with Hunter syndrome (MPS II). [More]
Sinovac selected to supply seasonal influenza vaccine to Beijing citizens

Sinovac selected to supply seasonal influenza vaccine to Beijing citizens

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today that it has been selected by the Beijing Centers for Disease Control and Prevention to be a supplier of the seasonal influenza vaccine to the citizens of Beijing for 2014. [More]
Ipsen’s Somatuline CLARINET Phase III study published online in NEJM

Ipsen’s Somatuline CLARINET Phase III study published online in NEJM

The U.S. affiliate of Ipsen today announced that the New England Journal of Medicine has published clinical trial results showing that Somatuline Autogel / Somatuline Depot (lanreotide) Injection 120 mg (referred to as Somatuline) achieved statistically significant prolongation of progression free survival (PFS) over placebo in patients with metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs). [More]