June 30, 2014

Afrezza, an inhaled insulin powder meant to treat diabetes patients, was approved Friday by the Food and Drug Administration.

June 27, 2014

The Food and Drug Administration on Thursday notified health professionals, their provider organizations and caregivers for infants, that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain.

June 27, 2014

Ohm Labs, a wholly owned subsidiary of Ranbaxy Labs, on Friday announced that it received approval from the Food and Drug Administration to manufacture and market valsartan tablets in 40 mg, 80 mg, 160 mg and 320 mg dosage strengths.

June 26, 2014

The Acetaminophen Awareness Coalition on Thursday released “Acetaminophen: How It’s Used, Preventing Overdose and What We Can Do to Promote Safe Use,” a report and educational resource to drive safe and appropriate use of one of the United States’ most common drug ingredients.

June 26, 2014

The Food and Drug Administration has issued a warning that certain OTC topical acne products may cause rare but serious and potentially life-threatening allergic reactions or severe irritation.

June 25, 2014

Massachusetts Governor Deval Patrick on Tuesday enacted biosimilars legislation updating Massachusetts’s pharmacy law and paving the way for the substitution of biosimilars deemed "interchangeable" by the Food and Drug Administration.

June 24, 2014

Nikki Haskell, the owner and CEO of Balanced Health Products, has been sentenced by a U.S. magistrate judge in a Manhattan federal court to a $60,000 fine for distributing dietary supplements that contained a prescription drug, the Food and Drug Administration reported Monday.

June 23, 2014

America’s biopharmaceutical research companies are developing 435 innovative new medicines to target 15 leading chronic conditions affecting the Medicare population, according to a new report released by the Pharmaceutical Research and Manufacturers of America last week.

June 23, 2014

The Food and Drug Administration announced that it has approved Sivextro (tedizolid phosphate), an antibacterial drug.

June 20, 2014

The Food and Drug Administration has published a draft guidance document for prescription drug supply chain stakeholders as part of the agency’s implementation of the Drug Supply Chain Security Act, the National Association of Boards of Pharmacy has reported.

June 18, 2014

There’s a lot happening in the allergy space right now. Chattem’s Nasacort Allergy 24HR recently hit store shelves, and in a little more than 10 weeks on the shelf the nasal corticosteroid has already generated $33.6 million in sales across total U.S. multi-outlets, according to IRI.

June 18, 2014

A survey co-released on Wednesday by the Generic Pharmaceutical Association and the National Coalition on Healthcare reveals that the healthcare providers patients rely on most to explain safety information about their prescription drugs have serious concerns about a proposed FDA rule on generic drug labeling.

June 18, 2014

A survey co-released Wednesday by the Generic Pharmaceutical Association and the National Coalition on Healthcare reveals that 8-in-10 healthcare providers have serious concerns about a proposed Food and Drug Administration rule on generic drug labeling.

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).