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.

May 12, 2014

Perrigo on Monday announced that it received approval from the Food and Drug Administration for azelastine hydrochloride nasal spray (0.15%), a generic version of Astepro. The drug is indicated for people ages 12 years and older and is used to treat nasal symptoms brought on by seasonal allergies or environmental irritants.

May 9, 2014

Bayer agreed to acquire the consumer care business of U.S. pharmaceutical company Merck for a purchase price of $14.2 billion. The OTC acquisition will give Bayer the global No. 2 position in nonprescription products following recently announced consolidations in this growing healthcare industry segment, and will significantly enhance Bayer’s business across multiple therapeutic categories and geographies. Merck's consumer care business includes such leading brands as Claritin, Coppertone and Dr. Scholl’s. Pro forma sales of the combined businesses in 2013 amounted to $7.4 billion with Merck’s business contributing approximately $2.2 billion.

Upon completion of the acquisition, Bayer is expected to achieve global leadership positions in dermatology and gastrointestinals and advance to the No. 2 position in the cold, allergy, sinus and flu category. Bayer will remain No. 2 in nutritionals and No. 3 in analgesics. Overall, the proposed GlaxoSmithKline-Novartis combination represents the largest consumer health business with about 5.7% share, according to reports. The Bayer/Merck combination comes in second with around 4.5% share. McNeil Consumer rounds out the top three globally with a share just above 4%.

May 9, 2014

Propeller Health, the FDA-cleared digital health solution for chronic respiratory disease, earlier this week announced that the Food and Drug Administration granted 510(k) clearance to market its latest generation of the Propeller platform, including a new sensor.

May 9, 2014

The Food and Drug Administration on Thursday approved Zontivity (vorapaxar) tablets, an anti-platelet agent that's designed to decrease the tendency of platelets to clump together to form a blood clot.

May 8, 2014

Actavis announced that it has launched a generic version of Boehringer Ingelheim's Catapres-TTS (clonidine transdermal system, USP, 0.1-mg/day, 0.2-mg/day, and 0.3-mg/day for one week).

May 8, 2014

Breyers announced that it will begin offering 36 gluten-free varieties. The varieties will feature a "gluten-free" claim, in line with the Food and Drug Administration's rule on gluten-free labeling.

May 6, 2014

AstraZeneca on Tuesday announced the Food and Drug Administration approved Epanova (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500 mg/dL).

May 6, 2014

The Food and Drug Administration's Nonprescription Drugs Advisory Committee on Friday voted 11-4 opposed to switching Merck's allergy remedy Singulair from Rx-to-OTC, according to an Associated Press report.

May 6, 2014

Pfizer's Nexium 24HR will launch May 27, Pfizer reported in a conference call Monday.

May 5, 2014

The Generic Pharmaceutical Association on Monday hired Felecia Tan for the role of AVP sciences and regulatory affairs.

May 5, 2014

Teva Pharmaceutical Industries on Monday announced that the Food and Drug Administration approved Synribo (omacetaxine mepesuccinate) for injection, to include home administration.

May 1, 2014

GlaxoSmithKline on Wednesday announced that the Food and Drug Administration approved Incruse Ellipta (umeclidinium), which is used for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, or COPD, including chronic bronchitis and/or emphysema.

May 1, 2014

Purdue Pharma on Wednesday announced that it filed a new drug application with the Food and Drug Administration to market a hydrocodone bitartrate tablet, which is formulated to incorporate abuse-deterrent technology.

April 30, 2014

The Food and Drug Administration on Tuesday granted approval to Zykadia (ceritinib) for patients with a specific type of late-stage (metastatic) non-small cell lung cancer (NSCLC).

April 29, 2014

Jubilant Life Sciences, an integrated pharmaceuticals and life sciences company, last week announced that it received approval from the Food and Drug Administration for spironolactone tablets, 25 mg, 50 mg and 100 mg, which is the generic version of Aldactone.