New Drug Application News and Research

RSS

FDA grants Priority Review for Repligen's SecreFlo NDA

Repligen Corporation announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the Company's new drug application (NDA) for SecreFlo for the improved detection of pancreatic duct abnormalities in patients with pancreatitis.

21 Feb 2012

S1 submits Lorexys IND application for HSDD and Female Sexual Dysfunction treatment

S1 Pharmaceuticals, Inc. (S1) announced today that it has submitted its Investigational New Drug (IND) application to the U.S. Food and Drug Administration for Phase I-b clinical studies of SIP-104 (Lorexys). Lorexys is the Company's lead drug candidate for the treatment of Hypoactive Sexual Desire Disorder (HSDD) and Female Sexual Dysfunction (FSD).

21 Feb 2012

Pfizer, Mylan enter settlement agreement to resolve e-cue patent litigation

Mylan Inc. and Pfizer Inc. today announced that Meridian Medical Technologies, a Pfizer subsidiary, has entered into a settlement agreement with Intelliject and Sanofi-Aventis that will resolve pending patent litigation related to Intelliject's 505(b)(2) new drug application (NDA) for its epinephrine auto-injector known as e-cue, which will be manufactured and marketed by Sanofi-Aventis.

16 Feb 2012

Acorda's fourth quarter GAAP net income increases to $12.7 million

Acorda Therapeutics, Inc. today announced its financial results for the fourth quarter and full year ended December 31, 2011.

16 Feb 2012

U.S. FDA accepts Pfizer's tafamidis NDA for treatment of TTR-FAP

Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for tafamidis meglumine, the company's investigational, novel, oral therapy for the treatment of Transthyretin Familial Amyloid Polyneuropathy.

16 Feb 2012

FDA accepts Gilead's Truvada sNDA and grants Priority Review

Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) and granted a six-month Priority Review for once-daily Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection among uninfected adults.

14 Feb 2012

Progesterone vaginal gel 8% NDA transferred to Watson

Columbia Laboratories, Inc., and Watson Pharmaceuticals, Inc., today announced that Columbia has transferred the new drug application for progesterone vaginal gel 8% for use in the reduction of risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy (NDA 22-139) to Watson.

13 Feb 2012

Santarus initiates enrollment in UCERIS Phase IIIb study for ulcerative colitis

Santarus, Inc. today announced that it has begun patient enrollment in a multicenter, randomized, double-blind, placebo-controlled Phase IIIb clinical study with the investigational drug UCERIS (budesonide) tablets 9 mg to evaluate whether there is an incremental benefit when UCERIS 9 mg is added to current oral aminosalicylate (5-ASA) therapy for patients with mild or moderate active ulcerative colitis who are not adequately controlled on background 5-ASA therapy.

13 Feb 2012

Watson seeks FDA approval to market generic Beyaz

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Drospirenone and Ethinyl Estradiol and Levomefolate Calcium Tablets, 3.0 mg/0.02 mg/0.451 mg and Levomefolate Calcium Tablets, 0.451 mg.

13 Feb 2012

Taro fourth quarter net sales increase 44.3% to $148.1 million

Taro Pharmaceutical Industries Ltd. today provided unaudited financial results for the quarter and full year ended December 31, 2011.

10 Feb 2012

Mylan's generic Doryx ANDA receives final FDA approval

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Doxycycline Hyclate Delayed-release (DR) Tablets USP, 150 mg. This product is the generic version of Mayne Pharma's Doryx, which is a tetracycline-class antimicrobial.

9 Feb 2012

Watson settles ORTHO TRI-CYCLEN LO patent litigation with Janssen

Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc., has reached a settlement with Janssen Pharmaceuticals, Inc. on outstanding patent litigation related to Watson's generic version of Janssen's ORTHO TRI-CYCLEN LO (norgestimate/ethinyl estradiol) tablets.

8 Feb 2012

Merck completes two suvorexant Phase III trials on insomnia

Merck, known as MSD outside the United States and Canada, today provided an update on the development program for suvorexant, the company's investigational orexin receptor antagonist, which, if approved, will be a new mechanism for the treatment of insomnia.

7 Feb 2012

EpiCept seeks FDA Fast Track designation for AmiKet to treat CIPN

EpiCept Corporation today announced that it has filed for Fast Track designation for AmiKet(amitriptyline 4%, ketamine 2% cream) for the treatment for chemotherapy-induced peripheral neuropathy (CIPN) with the U.S. Food and Drug Administration.

7 Feb 2012

FDA clears Neurelis IND to commence NRL-1 clinical trials for acute breakthrough seizures

Neurelis, Inc. today announced that the United States Food and Drug Administration (FDA) has cleared an Investigational New Drug application (IND) to commence clinical trials advancing the development of NRL-1 for the treatment of acute breakthrough seizures.

7 Feb 2012

Mylan acquires two dermatological drugs from Valeant

Mylan Inc. today announced that it has successfully completed the acquisition of two dermatological products from Valeant Pharmaceuticals.

6 Feb 2012

Orexigen reaches SPA agreement for Contrave outcomes trial with FDA

Orexigen Therapeutics, Inc. today announced that it has reached agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment for the Contrave outcomes trial.

6 Feb 2012

Sandoz sends Remodulin Paragraph IV Notice Letter to United Therapeutics

United Therapeutics Corporation today announced receipt of a Paragraph IV Certification Notice Letter on February 3, 2012 from Sandoz Inc. advising that Sandoz has submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration requesting approval to market a generic version of the 10 mg/mL strength of Remodulin (treprostinil) injection.

6 Feb 2012

Watson: ANDA for generic Lidoderm remains on track

In response to investment community speculation following release of the transcript of a pre-trial conference call related to its Lidoderm patent challenge, Watson Pharmaceuticals, Inc. today issued the following statement: Watson's abbreviated new drug application (ANDA) for a generic version of Lidoderm remains on track.

4 Feb 2012

AHF calls for top to bottom shake-up of management at FDA

AIDS Healthcare Foundation (AHF) today called for a top to bottom shake-up of the management at the Food and Drug Administration as well as a Congressional investigation following the publication of a Washington Post news article (1/31/12) that reported, "…the Food and Drug Administration secretly monitored the personal e-mail of a group of its own scientists and doctors after they warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients."

3 Feb 2012