Nasal Spray News and Research

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Contaminated nasal spray associated with rare bacterial outbreak

Infection control researchers investigating a rare bacterial outbreak of Burholderia cepacia complex (Bcc) identified contaminated nasal spray as the root cause of the infections, leading to a national recall of the product.

22 Jul 2011

Meda presents new positive results from Dymista Phase-III trial on AR at EAACI 2011

Meda presents new positive results from a Phase-III clinical trial of Dymista at the annual meeting of the European Academy of Allergy and Clinical Immunology (EAACI) in Istanbul, Turkey.

15 Jun 2011

Nose spray vaccine for type 1 diabetes could be a reality soon

Melbourne researchers are nearing the development of a vaccine for type 1 diabetes, after showing that a nasal spray can stop the body's immune system from attacking insulin-producing cells.

13 Jun 2011

FDA accepts Sunovion ciclesonide HFA nasal aerosol NDA for review

Sunovion Pharmaceuticals Inc. today announced that the New Drug Application (NDA) submitted for ciclesonide nasal aerosol in a hydrofluoroalkane (HFA) formulation has been accepted by the U.S. Food and Drug Administration.

6 Jun 2011

FDA approves Amneal's generic Furadantin

Amneal Pharmaceuticals, LLC is pleased to announce that it has received U.S. FDA approval to manufacture Nitrofurantoin Oral Suspension in the 25 mg/5 ml strength effective May 13, 2011. Amneal's generic, the first on the market, is an AA-rated, therapeutically equivalent alternative to Furadantin.

23 May 2011

Daiichi Sankyo, Regency Therapeutics launch SPRIX Nasal Spray for severe pain

Regency Therapeutics, a newly established division of Luitpold Pharmaceuticals, Inc., and its co-promotion partner Daiichi Sankyo, Inc., announced today that they have launched SPRIX® (ketorolac tromethamine) Nasal Spray and that it is now commercially available.

17 May 2011

Inhalation therapy might halt and reverse progression of pulmonary arterial hypertension

Patients with pulmonary arterial hypertension struggle with severe symptoms, which include shortness of breath, exhaustion and a lack of vitality. Moreover, the disease, which is more common in women, often claims the patient's life within a few years of its development.

6 May 2011

Luitpold temporarily suspends distribution of drug products manufactured at Shirley, New York facility

Luitpold Pharmaceuticals, Inc. today announced that it has temporarily suspended distribution of all of its drug products manufactured at its Shirley, New York facility and marketed by its American Regent, Inc. subsidiary and Animal Health Division.

22 Apr 2011

FDA grants tentative approval for Hi-Tech Pharmacal's generic Combigan ANDA

Hi-Tech Pharmacal Co., Inc., a specialty pharmaceuticals company, announced today that the US Food and Drug Administration, (FDA) granted tentative approval for the Company's Abbreviated New Drug Application, (ANDA) for brimonidine tartrate with timolol maleate ophthalmic solution, the generic for Allergan's Combigan® ophthalmic solution which had sales of $108 million for the 12 months ended December 2010 according to IMS sales data.

8 Apr 2011

U.S. Marshals, FDA seize $6 million worth Triad antiseptic products

U.S. Marshals, at the request of the U.S. Food and Drug Administration, today seized more than $6 million in products distributed by Triad Group Inc., at the company's facility in Hartland, Wis.

7 Apr 2011

Positive Phase 3 results from Tarsa's ORACAL study validates Unigene's oral peptide drug delivery technology

Unigene Laboratories, Inc. a leader in the design, delivery, manufacture and development of peptide-based therapeutics announced today that the statistically significant top-line results released by its licensee, Tarsa Therapeutics, validate its proprietary oral peptide drug delivery technology.

25 Mar 2011

Positive results from Tarsa's oral calcitonin Phase III trial against postmenopausal osteoporosis

Tarsa Therapeutics today announced that the Phase III ORACAL trial of its oral recombinant salmon calcitonin in the treatment of postmenopausal osteoporosis was successfully concluded and yielded statistically significant, positive top-line results.

25 Mar 2011

Positive results from Meda's Dymista Phase III trial in patients with SAR

Meda announced today positive results from a Phase III clinical trial of Dymista, a novel formulation of azelastine hydrochloride and fluticasone propionate, in patients with seasonal allergic rhinitis.

22 Mar 2011

Hi-Tech Pharmacal acquires rights to Nystatin Oral suspension ANDA from Bausch + Lomb

Hi-Tech Pharmacal Co., Inc. announced that it has acquired the rights to the Abbreviated New Drug Application (ANDA) for Nystatin Oral suspension from Bausch + Lomb, the global eye health company for an undisclosed upfront payment and a future royalty.

21 Mar 2011

Experts offer myth-busting advice to fight against spring allergies

Millions of Americans sneeze and wheeze March through June when they use misinformation to manage their spring allergies.

27 Feb 2011

Nasal spray vs. injection -- what would you prefer?

Adelaide researchers have taken a step closer to the development of a universal flu vaccine, with results of a recent study showing that a vaccine delivered by a simple nasal spray could provide protection against influenza.

19 Feb 2011

FDA grants final approval for Hi-Tech Pharmacal's ANDA for levofloxacin ophthalmic solution

Hi-Tech Pharmacal Co., Inc., a specialty pharmaceuticals company, announced today that the US Food and Drug Administration granted final approval for the Company's Abbreviated New Drug Application for levofloxacin ophthalmic solution, 0.5% the generic for Vistakon's Quixin ophthalmic solution, which had sales of $2 million for the 12 months ended December 2010 according to IMS sales data.

10 Feb 2011

Merck reports GAAP net income of $861 million for 2010

Merck, known as MSD outside the United States and Canada, today announced financial results for the fourth quarter and full year of 2010. The company reported non-GAAP (generally accepted accounting principles) earnings per share (EPS) for the fourth quarter of $0.88, which excludes purchase accounting adjustments, restructuring costs and merger-related expenses.

4 Feb 2011

MAP Pharmaceuticals, Allergan collaborate for LEVADEX to treat acute migraine in adults

Allergan, and MAP Pharmaceuticals, today announced a collaboration within the United States for LEVADEX, a self-administered, orally inhaled therapy that has completed Phase III clinical development for the treatment of acute migraine in adults.

31 Jan 2011

Collaborative study may lead to improved influenza vaccine and vaccines for other respiratory virus infections

A collaborative project between researchers at the Trudeau Institute and their colleagues at St. Jude Children's Research Hospital in Memphis, Tenn., offers new insights that may lead to an improved strategy to protect against the influenza virus and other viruses that infect the respiratory tract.

19 Jan 2011