New Drug Application News and Research

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Update on the status of Somaxon Pharmaceuticals' NDA for Silenor provided

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today provided an update on the status of its New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia.

22 Jan 2010

Scientific/technical review for XIAFLEX' European MAA commences

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, today announced that its partner Auxilium Pharmaceuticals, Inc. announced that Pfizer Inc. received notification from the European Medicines Agency that the Marketing and Authorization Application (MAA) for XIAFLEX™ for the treatment of Dupuytren's disease (a debilitating disorder resulting from excessive collagen deposition that causes contractures of the fingers) has completed the validation phase successfully and that the scientific/technical review procedure commenced today.

21 Jan 2010

Teva Pharmaceutical Industries receives FDA tentative approval for generic Femara Tablets

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Novartis’ breast cancer treatment Femara® (letrozole) Tablets, 2.5 mg. Final approval of Teva’s Letrozole Tablets is expected upon expiry of patent protection for the brand product in June 2011.

21 Jan 2010

USPTO issues Notice of Allowance for IntelGenx's bupropion patent

IntelGenx Corp. ("IntelGenx") today announced that the U.S. Patent and Trademark Office ("USPTO") has issued a formal Notice of Allowance for a key patent application protecting IntelGenx's CPI-300, a novel, high strength formulation of bupropion hydrochloride ("HCl"), the active ingredient in Wellbutrin XL(R).

21 Jan 2010

Endo Pharmaceuticals' partners receive Paragraph IV Certification Notice regarding LIDODERM

Endo Pharmaceuticals announced today that its partners, Teikoku Seiyaku Co., Ltd. and Teikoku Pharma USA, Inc. have received a Paragraph IV Certification Notice from Watson Laboratories, Inc. advising of the filing of an Abbreviated New Drug Application (ANDA) for a generic version of LIDODERM® (lidocaine topical patch 5%).

20 Jan 2010

Watson Laboratories files ANDA for Lidoderm

19 Jan 2010

FDA extends Tarceva's sNDA review period

OSI Pharmaceuticals, Inc. and Genentech, Inc., a wholly owned member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for Tarceva® (erlotinib) as a first-line maintenance therapy in advanced non-small cell lung cancer (NSCLC) by an additional 90 days.

18 Jan 2010

Vion Pharmaceuticals files SPA for Onrigin-LDAC combination Phase II/III trial

VION PHARMACEUTICALS, INC. announced today that it had filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) related to a randomized Phase II/III trial of its oncology therapeutic Onrigin™ (laromustine) Injection in combination with low-dose Ara-C (LDAC) in elderly patients with newly diagnosed acute myeloid leukemia (AML). The primary objective for the Phase III part of this study is to determine if Onrigin™ plus LDAC improves overall survival compared with LDAC alone.

12 Jan 2010

Mylan sued in connection with the filing of ANDA with FDA for Armodafinil Tablets

Mylan Inc. (Nasdaq: MYL) today confirmed that it was sued by Cephalon Inc. and Cephalon France in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Armodafinil Tablets, 50 mg, 150 mg and 250 mg.

12 Jan 2010

NicOx, TOPIGEN Pharmaceuticals terminate TPI 1020 collaboration

NicOx S.A. today announced that NicOx and TOPIGEN Pharmaceuticals Inc. have mutually terminated their collaboration for TPI 1020. This decision was made as a result of the acquisition of TOPIGEN by Pharmaxis announced yesterday.

12 Jan 2010

Second pivotal efficacy study not required for MAP Pharmaceuticals' LEVADEX NDA

MAP Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that a second pivotal efficacy study is not required for the Company's LEVADEX(TM) new drug application (NDA) submission for the acute treatment of migraine. The Company announced in May 2009 that the efficacy portion of its Phase 3 FREEDOM-301 clinical study of LEVADEX met all four primary endpoints. The Company had previously anticipated initiating a second pivotal efficacy study in the first quarter of 2010.

12 Jan 2010

Positive results from KemPharm's KP106 Phase 1 clinical trial for ADHD

KemPharm, Inc. today announced positive results from a Phase 1 clinical trial of KP106, its novel prodrug for attention-deficit hyperactivity disorder (ADHD). KP106, a new chemical entity (NCE) composed of the active pharmaceutical compound d-amphetamine and a ligand, was created using KemPharm’s proprietary Ligand Activated Therapy (LAT) prodrug approach.

12 Jan 2010

Targacept signs collaboration and license agreement with AstraZeneca

Targacept, Inc., a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics™, today announced that its collaboration and license agreement with AstraZeneca for the global development and commercialization of TC-5214 for major depressive disorder (MDD) has become effective as a result of early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

11 Jan 2010

A.P. Pharma regains compliance for continued listing on Nasdaq Capital Market

A.P. Pharma, Inc., a specialty pharmaceutical company, today announced that, on January 7, 2010, it received notice from the Nasdaq Stock Market (Nasdaq) confirming that the Company has regained compliance with the $1.00 minimum closing bid price requirement for continued listing on The Nasdaq Capital Market under Listing Rule 5450(a)(1).

11 Jan 2010

A.P. Pharma receives final milestone payment of $2.5M from Paul Capital Healthcare

A.P. Pharma, Inc., a specialty pharmaceutical company, today announced it has received the final milestone payment of $2.5 million from an affiliate of Paul Capital Healthcare.

11 Jan 2010

EpiCept, Meda enter into exclusive commercialization agreement for Ceplene

EpiCept Corporation announced today that it has entered into an exclusive commercialization agreement for Ceplene® (histamine dihydrochloride) with Meda AB, a leading international specialty pharmaceutical company based in Stockholm. Ceplene is EpiCept’s novel therapy approved in the European Union with orphan drug status for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first remission.

11 Jan 2010

Vertex Pharmaceuticals plans proof-of-concept clinical trials in RA and epilepsy

Vertex Pharmaceuticals Incorporated today provided an update on key 2010 business priorities in conjunction with the 28th Annual J.P. Morgan Healthcare Conference in San Francisco. The company also discussed recent progress in its lead development programs in hepatitis C virus (HCV) infection and cystic fibrosis (CF) and outlined proof-of-concept clinical trials planned in other serious diseases for 2010.

11 Jan 2010

FDA yet to review MannKind’s NDA for insulin therapy

MannKind Corporation announced that it was informed today by the Food and Drug Administration that the FDA will not be able to complete the review of MannKind’s new drug application (NDA) for its ultra rapid-acting insulin therapy by the action date of January 16, 2010.

9 Jan 2010

Green Cross seeks regulatory approval for peramivir in S.Korea

BioCryst Pharmaceuticals, Inc. today announced that it has been informed by its partner, Green Cross Corp., that Green Cross has filed a New Drug Application (NDA) in South Korea to seek regulatory approval for intravenous (i.v.) peramivir to treat patients with influenza.

9 Jan 2010

Watson Pharmaceuticals files ANDA with FDA seeking approval to market LoSeasonique

Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc., has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its levonorgestrel and ethinyl estradiol (0.10 mg/0.02 mg) oral contraceptive product prior to the expiration of U.S. Patent No. 7,615,545, which is owned by Duramed Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceutical Industries, Ltd.

9 Jan 2010