June 9, 2014

Strides Arcolab last week received approval from the Food and Drug Administration for methoxsalen capsules USP, 10-mg (soft gelatin capsules).

June 6, 2014

Upsher-Smith Laboratories on Wednesday announced that it has received final approval from the Food and Drug Administration for its new drug application for Vogelxo (testosterone) gel for topical use CIII.

June 3, 2014

Indian drug maker Wockhardt has been charged by the Food and Drug Administration with utilizing the same unapproved method to test drug quality in its Morton Grove, Ill., facility as two facilities in India, both of which were subsequently banned from importing into the United States,the Wall Street Journal reported Tuesday.

June 2, 2014

Mylan announced on Monday that it has entered into a settlement and license agreement with Pfizer relating to Mylan's abbreviated new drug application filed with the U.S. Food and Drug Administration for celecoxib capsules in 50-mg, 100-mg, 200-mg and 400-mg strengths.

May 30, 2014

Teva Pharmaceutical Industries announced on Friday that the U.S. District Court for the Northern District of West Virginia has denied a motion filed by Mylan and issued an opinion and order affirming a decision by the FDA under which Teva should receive sole 180-day “first-to-file” exclusivity for generic Celebrex (celecoxib) 100-, 200- and 400-mg capsules.

May 29, 2014

Depomed on Wednesday announced that the Food and Drug Administration has accepted for filing a new drug application from Mallinckrodt for MNK-155.

May 29, 2014

Trimel Pharmaceuticals on Wednesday announced that the Food and Drug Administration has approved Natesto (testosterone), formerly CompleoTRT, the first and only testosterone nasal gel for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

May 29, 2014

Mylan on Thursday announced that it has launched atovaquone and proguanil hydrochloride tablets, 62.5 mg/25 mg and 250 mg/100 mg, the generic version of GlaxoSmithKline's Malarone tablets.

May 28, 2014

Actavis on Tuesday confirmed that it has filed an abbreviated new drug application with the Food and Drug Administration seeking approval to market saxagliptin hydrochloride tablets, 2.5 mg and 5 mg.

May 28, 2014

Taro Pharmaceutical Industries posted a net sales increase of 13.2% to $759.3 million for its fiscal year ended March 31.

May 23, 2014

The Food and Drug Administration on Friday approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with acute bacterial skin and skin structure infections.

May 23, 2014

The Food and Drug Administration took action this week against websites that sell potentially dangerous, unapproved prescription drugs to U.S. consumers.

May 23, 2014

Teva Pharmaceutical on Friday announced that the Food and Drug Administration approved the use of QVAR (beclomethasone dipropionate HFA) with a dose counter for the treatment of asthma in patients 5 years of age and older.

May 22, 2014

Delegates from the member boards of pharmacy adopted eight resolutions during the National Association of Boards of Pharmacy 110th Annual Meeting held in Phoenix.

May 21, 2014

Minnesota Gov. Mark Dayton last week signed a bill that will prohibit the use of the antibacterial ingredient triclosan in consumer hygiene products beginning Jan. 1, 2017, according to an Associated Press report published Monday.

May 21, 2014

Takeda Pharmaceutical on Tuesday announced that the Food and Drug Administration simultaneously approved a new biologic therapy, Entyvio (vedolizumab), for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease.

May 16, 2014

The Food and Drug Administration on Thursday announced it required Sunovion Pharmaceuticals, manufacturer of the sleep drug Lunesta (eszopiclone), to change the drug label and lower the current recommended starting dose.

May 16, 2014

Pfizer announced plans to submit a new drug application with the Food and Drug Administration for palbociclib, which is used for the first-line systemic treatment of post-menopausal women with advanced or metastatic breast cancer.

May 14, 2014

Actavis on Tuesday announced that it has received final approval from the Food and Drug Administration on its abbreviated new drug application for a generic version of Mallinckrodt's Exalgo (hydromorphone hydrochloride extended-release tablets 8 mg, 12 mg and 16 mg).

May 14, 2014

The Food and Drug Administration moved one step closer to establishing a biosimilar pathway with a new guidance document explaining how to use clinical pharmacology data to show similarity to a reference product, according to a report published by Regulatory Focus on Tuesday.

May 13, 2014

Teva Pharmaeceuticals on Tuesday announced that the Food and Drug Administration accepted the company's supplemental new drug application for a lower dose QNASL (beclomethasone dipropionate) nasal aerosol, which is used for the treatment of seasonal and perennial allergic rhinitis in children ages 4 years to 11 years.

May 12, 2014

Bayer HealthCare on Monday announced that the Food and Drug Administration approved the company's new indication for Bayer's Kogenate FS antihemophilic factor VIII (recombinant) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.

May 12, 2014

The Consumer Healthcare Products Association on Friday filed comments to the Food and Drug Administration in response to the agency’s Notice of Public Hearing and Request for Comments on the Over-the-Counter Drug Monograph System, also referred to as the OTC Drug Review.

May 12, 2014

Lundbeck and Chelsea Therapeutics International last week announced an agreement under which Lundbeck will acquire Chelsea.