KV Pharmaceuticals announced that partner Hologic Inc. re-submitted for the Food and Drug Administration approval of Gestiva (Hydroxyprogesterone Caproate) an injectable drug indicated to prevent preterm birth in women who are pregnant with a single baby and have spontaneously delivered a single baby preterm in the past.

Teva Pharmaceutical Industries Ltd. Cleared by the Food and Drug Administration for Pfizer´s Effexor XR drug, indicated to treat depression.

Depomed Inc. said that the Food and Drug Administration accepted review of daily dose experimental drug to treat postherpetic neuralgia, DM 1796 (Gabapentin ER). The drug will be marketed by Abbott Laboratories Inc.

US-based Abbott Laboratories Inc. and AstraZeneca Plc. Presented to the Food and Drug Administration for approval their experimental drug Cetriad, a combination of statin blockbuster Crestor and fenofibrato Triplix.

GlaxoSmithKline and XenoPort Inc. announced the withdrawal of an application for approval by the Food and Drug Administration of Solzira, a drug for restless legs syndrome. The decision delays $23 million in milestone payments to XenoPort from GSK and Astellas Pharma.

Japan´s Takeda Pharmaceutical Co has reported that the U.S. Food and Drug Administration (FDA) has not been able to complete a review of their key diabetes drug candidate SYR-322 (alogliptin) on schedule due to lack of resources.

Transcept Pharmaceuticals, Inc announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its candidate Intermezzo (zolpidem tartrate) a sublingual lozenge treating insomnia (middle-of-the-night awakenings with difficulty of returning to sleep).

Indevus Pharmaceuticals, Inc. announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) with regard to the additional data and risk management strategy that will lead to re-submission (complete response) of the New Drug Application (NDA) for Nebido in the first quarter 2009.

Takeda Pharmaceutical Co announced it has applied for approval by the Food and Drug Administration to market in the U.S. SYR-322 (alogiptin) and Actos diabetes drugs in a combined single tablet for the treatment of type 2 diabetes.

Labopharm Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for DDS-04A, for the treatment of major depression.

GlaxoSmithKline Plc and XenoPort, Inc. announced today that a New Drug Application (NDA) has been submitted to the Food and Drug Administration (FDA) requesting approval of Solzira (gabapentin enacarbil) for the treatment of moderate-to-severe primary Restless Legs Syndrome

Bayer AG´s key new anticoagulant drug Xarelto has been submitted for approval to the U.S. Food and Drug Administration (FDA) by partner Johnson & Johnson (J&J). The EMEA gave a positive recommendation last week. Bayer/J&J aiming for stroke prevention indication. Further details.

Anglo-Swedish drugmaker AstraZeneca filed a NDA to the U.S. FDA and applied for marketing authorization to European authorities for its novel diabetes treatment Onglyza. Analysts deem that Astra and partner Bristol-Myers Squibb could reap blockbuster rewards from Onglyza

Autralian based biotech ChemGenex Pharmaceuticals Ltd submitted to the Food and Drug Administration the first of three parts of a new application for omacetaxine designed to fight chronic myeloid leukemia.

U.K.’s Glaxo has submitted its novel anti-nausea drug Rezonic, also known as Zunrisa, for U.S. regulatory approval. The drugmaker included Phase 3 results unveiled at the 44th Annual Meeting of the American Society of Clinical Oncology that confirm the drug’s effectiveness. Designed to relieve chemotherapy-induced nausea and vomiting, analysts hail Glaxo’s new promise as a potential blockbuster. Rezonic could easily generate $1.5 billion a year

Denmark’s Novo Nordisk has submitted a New Drug Application (NDA) to the U.S. FDA and a marketing authorization application to the European Medicines Agency (EMEA) for the approval of liraglutide, its novel candidate for treatment of type 2 diabetes. A once-daily human GLP-1 analogue, liraglutide has been hailed as a promising treatment which enhances glycemic control without increasing weight

The FDA has told U.K.’s Glaxo and U.S. Adolor that it will not be issuing an action letter on the NDA for their anti-constipation drug Entereg for postoperative ileus by May 10, as had been previously scheduled. The FDA failed to provide a specific date, though it expects to issue the action letter shortly. GSK and Adolor have been trying to gain FDA approval for Entereg since 2006