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FDA accepts Iroko Pharmaceuticals' ZORVOLEX sNDA for review

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced that the U.S. Food and Drug Administration has accepted for review the Supplemental New Drug Application for ZORVOLEX (diclofenac), a lower dose nonsteroidal anti-inflammatory drug, for the proposed indication of treatment of osteoarthritis pain in adults. ZORVOLEX was approved by FDA in October 2013 for the treatment of mild to moderate acute pain in adults.

15 Jan 2014

Colgate offers easy-to-follow tips to help women stay on track for better, healthy lifestyle this year

The start of a new year is often a time for reflection and a resolve to change. Whether the resolutions are big or small, most people by now are already starting down the path to a new and better version of themselves.

10 Jan 2014

Mylan announces launch of Mycophenolic Acid Delayed-release Tablets

Mylan Inc. today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Mycophenolic Acid Delayed-release Tablets, 180 mg and 360 mg. This product is the generic version of Novartis' Myfortic Delayed-release Tablets.

9 Jan 2014

FDA approves Actavis' ANDA for Telmisartan Immediate-Release Tablets

Actavis plc today announced that it has received approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for Telmisartan Immediate-Release Tablets, 20 mg, 40 mg and 80 mg, a generic equivalent to Boehringer Ingelheim's Micardis. Actavis intends to launch the product immediately.

9 Jan 2014

Mylan launches Tolterodine Tartrate ER Capsules, 2 mg and 4 mg

Mylan Inc. today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Tolterodine Tartrate Extended-release Capsules, 2 mg and 4 mg. Tolterodine Tartrate ER Capsules are the generic version of Pfizer's Detrol LA, and are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for this product.

7 Jan 2014

Shield Therapeutics reports positive top-line data from pivotal Phase 3 programme of ST10

Shield Therapeutics, an independent specialty pharmaceutical company focused on the development of mineral-derived hospital pharmaceuticals, today announces strongly positive top-line data from the pivotal Phase 3 programme of ST10 for the treatment of iron deficiency anaemia in inflammatory bowel disease.

7 Jan 2014

Aeterna Zentaris announces FDA acceptance for filing of macimorelin acetate NDA for AGHD

Aeterna Zentaris Inc. today announced that the U.S. Food and Drug Administration has accepted for filing the Company's New Drug Application for its ghrelin agonist, macimorelin acetate, in Adult Growth Hormone Deficiency. The acceptance for filing of the NDA indicates the FDA has determined that the application is sufficiently complete to permit a substantive review.

7 Jan 2014

FDA accepts Cubist Pharmaceuticals' tedizolid phosphate NDA with Priority Review

Cubist Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has accepted the Company's New Drug Application for its investigational antibiotic tedizolid phosphate (TR-701) with Priority Review. The FDA has assigned a Prescription Drug User Fee Act action date of June 20, 2014. Cubist is seeking FDA approval of tedizolid for the treatment of acute bacterial skin and skin structure infections.

30 Dec 2013

Veloxis Pharmaceuticals seeks FDA approval to market Envarsus for prevention of organ rejection

Veloxis Pharmaceuticals A/S, today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of Envarsus (formerly LCP-Tacro) for the prevention of organ rejection in kidney transplant recipients.

30 Dec 2013

Oramed Pharmaceuticals to purchase $15,800,000 shares in registered direct offering

Oramed Pharmaceuticals Inc., a developer of oral drug delivery systems, today announced that it has entered into definitive agreements with investors to purchase an aggregate of 1,580,000 shares of common stock at a price of $10.00 per share in a registered direct offering.

26 Dec 2013

Actavis' subsidiary files ANDA for generic version of NuvaRing

Actavis plc today confirmed that its subsidiary, Warner Chilcott Company LLC, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Ethinyl Estradiol and Etonogestrel Vaginal Ring, 0.015 mg/24 hour and 0.12 mg/24 hour.

26 Dec 2013

Actavis' subsidiary receives FDA complete response letter for progestin-only patch NDA

Actavis plc today confirmed that the Company's subsidiary has received a complete response letter from the U.S. Food and Drug Administration for its New Drug Application for a progestin-only transdermal contraceptive patch (Norethindrone Transdermal Delivery System) for use by women to prevent pregnancy.

24 Dec 2013

U.S. FDA grants Veloxis Orphan Drug status for Envarsus

Veloxis Pharmaceuticals A/S, today announced that Envarsus was granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) for prophylaxis of organ rejection in patients receiving allogenic kidney transplants.

24 Dec 2013

Lilly, Boehringer Ingelheim announce FDA acceptance of NDA filing for new insulin glargine product

Eli Lilly and Company and Boehringer Ingelheim today announced that the U.S. Food and Drug Administration has accepted the filing of the New Drug Application for LY2963016, an investigational basal (long-acting) insulin.

21 Dec 2013

Biocryst seeks FDA NDA approval for Peramivir to treat influenza

BioCryst Pharmaceuticals, Inc., a pharmaceutical company focused on the development and commercialization of treatments for rare and infectious diseases, today announced that it has submitted a New Drug Application (NDA) filing for intravenous (i.v.) peramivir to the U.S. Food & Drug Administration (FDA). BioCryst is seeking an indication as the first i.v. neuraminidase inhibitor approved in the U.S. for the treatment of acute uncomplicated influenza in adults. Peramivir is approved in Japan and Korea for the treatment of influenza.

20 Dec 2013

Oramed reports positive results from ORMD-0801 pharmacokinetic study in type 1 diabetes patients

Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today successful results in a clinical trial testing the pharmacokinetic dose response of its oral insulin capsule (ORMD-0801) in type 1 diabetes patients.

20 Dec 2013

Daiichi Sankyo submits LIXIANA supplemental NDA for review in Japan

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has submitted a supplemental New Drug Application for its oral, once-daily direct factor Xa-inhibitor LIXIANA® (Edoxaban Tosilate Hydrate) for review by the Japanese Ministry of Health, Labour and Welfare. Daiichi Sankyo is seeking approval in Japan for edoxaban in new indications for non-valvular atrial fibrillation and symptomatic venous thromboembolism.

19 Dec 2013

Nuvo Research, NovaMedica enter into agreement to market Pennsaid products in Russia

Nuvo Research Inc., a specialty pharmaceutical company with a diverse portfolio of products in the areas of topical pain and immunology, and NovaMedica LLC, a Russian pharmaceutical company, today announced that they have signed a supply and distribution agreement providing NovaMedica the exclusive rights to market and sell Nuvo's Pennsaid 1.5% and Pennsaid 2% products in Russia and some of the Community of Independent States.

19 Dec 2013

Helsinn, Mundipharma sign distribution and license agreement for investigational therapy

Helsinn and Mundipharma announce the signature of a new, exclusive license and distribution agreement, covering China, Hong Kong and Macao, for netupitant-palonosetron fixed dose combination, a Helsinn product under development for the treatment of chemotherapy-induced nausea and vomiting.

19 Dec 2013

Navidea seeks FDA approval for marketing Lymphoseek Injection for SLN detection

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that it has submitted a Supplemental New Drug Application with the U.S. Food and Drug Administration seeking approval for the marketing and sale of Lymphoseek (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer, an indication for which Lymphoseek was also granted Fast Track designation earlier this month.

17 Dec 2013

New Drug Application News and Research

FDA accepts Iroko Pharmaceuticals' ZORVOLEX sNDA for review

Colgate offers easy-to-follow tips to help women stay on track for better, healthy lifestyle this year

Mylan announces launch of Mycophenolic Acid Delayed-release Tablets

FDA approves Actavis' ANDA for Telmisartan Immediate-Release Tablets

Mylan launches Tolterodine Tartrate ER Capsules, 2 mg and 4 mg

Shield Therapeutics reports positive top-line data from pivotal Phase 3 programme of ST10

Aeterna Zentaris announces FDA acceptance for filing of macimorelin acetate NDA for AGHD

FDA accepts Cubist Pharmaceuticals' tedizolid phosphate NDA with Priority Review

Veloxis Pharmaceuticals seeks FDA approval to market Envarsus for prevention of organ rejection

Oramed Pharmaceuticals to purchase $15,800,000 shares in registered direct offering

Actavis' subsidiary files ANDA for generic version of NuvaRing

Actavis' subsidiary receives FDA complete response letter for progestin-only patch NDA

U.S. FDA grants Veloxis Orphan Drug status for Envarsus

Lilly, Boehringer Ingelheim announce FDA acceptance of NDA filing for new insulin glargine product

Biocryst seeks FDA NDA approval for Peramivir to treat influenza

Oramed reports positive results from ORMD-0801 pharmacokinetic study in type 1 diabetes patients

Daiichi Sankyo submits LIXIANA supplemental NDA for review in Japan

Nuvo Research, NovaMedica enter into agreement to market Pennsaid products in Russia

Helsinn, Mundipharma sign distribution and license agreement for investigational therapy

Navidea seeks FDA approval for marketing Lymphoseek Injection for SLN detection

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