New Drug Application News and Research

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ICS, Quintiles enter agreement with Pacira to support launch of EXPAREL

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced that it has entered into agreements with Quintiles Commercial US, Inc. and Integrated Commercialization Services, Inc. (ICS) to support the anticipated launch of EXPAREL, should it be approved by the Food and Drug Administration (FDA) later this year.

6 Sep 2011

Perrigo's ANDA for Ketoconazole Foam, 2% receives final FDA approval to treat seborrheic dermatitis

Perrigo Company today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for Ketoconazole Foam, 2%, the generic version of Extina Ketoconazole Foam, 2%.

31 Aug 2011

Favorable top-line results from Aeterna Zentaris' AEZS-130 Phase 3 study on AGHD

Aeterna Zentaris Inc. today announced favorable top-line results of its completed Phase 3 study with AEZS-130 as the first oral diagnostic test for Adult Growth Hormone Deficiency.

31 Aug 2011

FDA accepts Salix and Progenics' sNDA filing for RELISTOR to treat opioid-induced constipation

Progenics Pharmaceuticals, Inc. and Salix Pharmaceuticals, Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental New Drug Application (sNDA) for RELISTOR Subcutaneous Injection to treat opioid-induced constipation (OIC) in patients with non-cancer pain.

30 Aug 2011

Astellas seeks regulatory approval for mirabegron to treat overactive bladder in the U.S., Europe

Astellas Pharma Inc. today announced the submission of a New Drug Application and Market Authorisation Application for mirabegron to the U.S. Food and Drug Administration and the European Medicines Agency.

29 Aug 2011

Shire receives FDA marketing approval for FIRAZYR to treat acute attacks of HAE

Shire plc, the global specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for FIRAZYR for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

26 Aug 2011

Santarus, Depomed enter new commercialization agreement for GLUMETZA

Santarus, Inc. and Depomed, Inc. today announced that they have entered into a new commercialization agreement for GLUMETZA (metformin hydrochloride extended release tablets) under which Santarus will assume broad commercial, manufacturing and regulatory responsibilities to replace a promotion agreement that the companies entered into in July 2008.

23 Aug 2011

CTI responds to EMA's Day 120 letter for pixantrone MAA

Cell Therapeutics, Inc. today announced that it has submitted its response to the Day 120 List of Outstanding Issues to the European Medicines Agency's Committee for Medicinal Products for Human Use in regards to CTI's Marketing Authorization Application for pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma.

23 Aug 2011

FDA accepts Alexza ADASUVE NDA, assigns PDUFA action date

Alexza Pharmaceuticals, Inc. announced today that the U.S. Food & Drug Administration (FDA) has accepted the ADASUVE New Drug Application (NDA) as a complete, class 2 response to the FDA's action letter, with an indicated Prescription Drug User Fee Act (PDUFA) goal date of February 4, 2012.

20 Aug 2011

NPS submits NDA CMC section to FDA for GATTEX

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, today announced that it has submitted the chemistry, manufacturing and controls (CMC) section of its new drug application (NDA) for GATTEX® (teduglutide) to the U.S. Food and Drug Administration (FDA).

18 Aug 2011

EMA accepts Merck and ARIAD's MAA for ridaforolimus to treat metastatic bone sarcomas

Merck, known outside the United States and Canada as MSD, and ARIAD Pharmaceuticals, Inc., today announced that the European Medicines Agency (EMA) has completed its administrative validation process for the regulatory application for ridaforolimus, an investigational oral mTOR inhibitor developed for the treatment of metastatic soft-tissue or bone sarcomas in patients who had a favorable response to chemotherapy.

18 Aug 2011

Neoprobe sells gamma detection device business to Devicor

Neoprobe Corporation, a diversified developer of innovative oncology surgical and diagnostic products, announced today that it completed the previously announced sale of its neoprobe GDS line of gamma detection device systems to Devicor Medical Products, Inc. for $30 million in upfront consideration, plus up to an additional $20 million in royalties based on Devicor's achievement of certain revenue milestones.

18 Aug 2011

FDA accepts Protalix taliglucerase alfa NDA resubmission for review

Protalix BioTherapeutics, Inc., announced today that the U.S. Food & Drug Administration (FDA) has accepted for review the resubmission of the taliglucerase alfa New Drug Application (NDA) following the Company's receipt of a Complete Response Letter (CRL) in February 2011.

17 Aug 2011

Mylan confirms Frova patent challenge

Mylan Inc. today confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc. have been sued by Endo Pharmaceuticals in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Frovatriptan Succinate EQ, 2.5 mg base tablets.

17 Aug 2011

HSS, pSivida enter orthopedic evaluation agreement

Drug delivery company pSivida Corp. today announced it has entered into an evaluation agreement with Hospital for Special Surgery (HSS), a world leader in orthopedics, rheumatology and rehabilitation, to investigate pSivida's drug delivery technologies in orthopedics.

17 Aug 2011

Enrollment commences in Omthera's Epanova Phase III trial for hypertriglyceridemia

Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, announced today that the first patient has been enrolled in its ESPRIT Phase III clinical trial of Epanova, in patients with hypertriglyceridemia (TG level greater than or equal to 200 and < 500 mg/dL) despite treatment with a statin.

16 Aug 2011

Starpharma starts bacterial vaginosis prevention study of VivaGel

Starpharma Holdings Limited today announced the commencement of its Phase 2 study of VivaGel for the prevention of bacterial vaginosis (BV), following receipt of ethics approval.

15 Aug 2011

FDA assigns PDUFA action date for review of Affymax peginesatide NDA

Affymax, Inc. today announced that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of March 27, 2012 for the review of the investigational agent peginesatide New Drug Application.

12 Aug 2011

Pacira second quarter total revenues increase to $3.6 million

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced financial results for the second quarter ended June 30, 2011, provided an update on the execution of its pre-commercial and launch strategies for EXPAREL, and updated its 2011 financial guidance.

11 Aug 2011

Neoprobe seeks FDA marketing approval of Lymphoseek for use in ILM oncology procedure

Neoprobe Corporation, a diversified developer of innovative oncology surgical and diagnostic products, today announced it has submitted a New Drug Application (NDA) for Lymphoseek to the U.S. Food and Drug Administration.

11 Aug 2011

New Drug Application News and Research

ICS, Quintiles enter agreement with Pacira to support launch of EXPAREL

Perrigo's ANDA for Ketoconazole Foam, 2% receives final FDA approval to treat seborrheic dermatitis

Favorable top-line results from Aeterna Zentaris' AEZS-130 Phase 3 study on AGHD

FDA accepts Salix and Progenics' sNDA filing for RELISTOR to treat opioid-induced constipation

Astellas seeks regulatory approval for mirabegron to treat overactive bladder in the U.S., Europe

Shire receives FDA marketing approval for FIRAZYR to treat acute attacks of HAE

Santarus, Depomed enter new commercialization agreement for GLUMETZA

CTI responds to EMA's Day 120 letter for pixantrone MAA

FDA accepts Alexza ADASUVE NDA, assigns PDUFA action date

NPS submits NDA CMC section to FDA for GATTEX

EMA accepts Merck and ARIAD's MAA for ridaforolimus to treat metastatic bone sarcomas

Neoprobe sells gamma detection device business to Devicor

FDA accepts Protalix taliglucerase alfa NDA resubmission for review

Mylan confirms Frova patent challenge

HSS, pSivida enter orthopedic evaluation agreement

Enrollment commences in Omthera's Epanova Phase III trial for hypertriglyceridemia

Starpharma starts bacterial vaginosis prevention study of VivaGel

FDA assigns PDUFA action date for review of Affymax peginesatide NDA

Pacira second quarter total revenues increase to $3.6 million

Neoprobe seeks FDA marketing approval of Lymphoseek for use in ILM oncology procedure

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