June 17, 2014

Lannett Co. received approval from the Food and Drug Administration for codeine sulfate tablets USP, a schedule II controlled substance, in 15 mg, 30 mg and 60 mg dosage strengths.

June 17, 2014

Novartis on Tuesday announced that it had submitted a biologic license application to the Food and Drug Administration for marketing approval for the use of Bexsero.

June 13, 2014

Teva Pharmaceutical Industries on Thursday announced that the U.S. Court of Appeals for the Federal Circuit upheld a ruling by the U.S. District Court for the District of Delaware finding Bristol-Myers Squibb's entecavir compound claim of U.S. Patent No. 5,206,244 invalid.

June 12, 2014

Carex Health Brands on Thursday introduced AccuRelief Pain Relief Systems, a line of transcutaneous electrical nerve stimulation (TENS) therapy FDA–approved for full-body, over–the–counter use.

June 12, 2014

Valeant Pharmaceuticals International announced that its subsidiary, Valeant Pharmaceuticals North America, received approval from the Food and Drug Administration for its new drug application for Jublia (efinaconazole 10% topical solution). The drug is the first topical triazole approved for the treatment of onychomycosis of the toenails, the company said.

June 11, 2014

Strativa Pharmaceutical, a division of Par Pharmaceutical Cos., announced that the Food and Drug Administration approved Nascobal, a prescription B-12 supplement administered once a week as one spray.

June 10, 2014

The Food and Drug Administration last week published an interim final rule to further safeguard the health of infants fed infant formula in the United States.

June 9, 2014

BioDelivery Sciences International on Monday announced that the Food and Drug Administration approved its new drug application for Bunavail (buprenorphine and naloxone) buccal film (CIII).

June 9, 2014

Teva on Monday announced that the Food and Drug Administration approved an expanded label for Azilect (rasagiline tablets) from monotherapy and adjunct to levodopa to now include dopamine agonists.

June 9, 2014

A recently approved drug might make infusions for hemophiliacs fewer and further between. The Food and Drug Administration approved Biogen Idec's Eloctate, which clinical trials have shown works to treat bleeding episodes and to increase the time between prophylactic blood infusions for those with hemophilia A.

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.