February 13, 2014

Janssen Biotech announced that the Food and Drug Administration has approved Imbruvica (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia who have received at least one prior therapy.

February 4, 2014

Salix Pharmaceuticals announced that the Food and Drug Administration has accepted for filing a new drug application for Budesonide 2 mg Rectal Foam for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.

February 3, 2014

Onset Dermatologics, which makes prescription products for improving skin health, has announced the nationwide availability of Tretin-X (tretinoin, USP) Cream 0.075% for the treatment of acne.

January 24, 2014

Hi-Tech Pharmacal Co., a specialty pharmaceuticals company, announced that it was granted final approval from the Food and Drug Administration for bromfenac ophthalmic solution 0.09% (once-a-day).

January 24, 2014

Perrigo announced that it received final approval from the Food and Drug Administration for repaglinide tablets — a generic version of Prandin tablets.

January 15, 2014

Perrigo on Tuesday announced that it has received final approval for its abbreviated new drug application for fluocinonide cream 0.1%, the generic equivalent to prescription-only Vanos Cream 0.1%.

January 8, 2014

The Food and Drug Administration has approved a new drug made by Bristol-Myers Squibb and AstraZeneca for treating Type 2 diabetes, the agency said.

January 8, 2014

Takeda Pharmaceutical has started a late-stage clinical trial program of its experimental drug for inflammatory bowel disease in Japan, the company said Wednesday.

December 27, 2013

The Food and Drug Administration has approved an HIV pill made by Gilead Sciences for patients who are switching from other therapy regimens, the company said.

December 23, 2013

The Food and Drug Administration has approved a new drug made by United Therapeutics for treating pulmonary arterial hypertension, the company said Monday.

December 6, 2013

The Food and Drug Administration has approved a new drug for hepatitis C made by Gilead Sciences, the drug maker said Friday.

November 15, 2013

The Food and Drug Administration has approved a new drug for fungal infections of the skin made by Valeant Pharmaceuticals International, the drug maker said Friday.

November 14, 2013

Drug makers Johnson & Johnson and Pharmacyclics have added Avella Specialty Pharmacy to their limited-distribution network for a newly approved blood cancer drug.

November 13, 2013

Johnson & Johnson and Pharmacyclics have added a New York-based specialty pharmacy company focused on cancer to their limited-distribution network for a drug recently approved for a rare form of blood cancer.

November 8, 2013

Drug maker Eisai has launched a new version of a drug used to treat gastroesophageal reflux disease, the company said Friday.

November 6, 2013

Noven Pharmaceuticals has launched a new drug for severe hot flashes nationwide, the company said.

November 5, 2013

A recently released clinical trial has found that patients taking a biotech drug for arthritis and those taking a biosimilar version had similar responses to both treatments.

November 4, 2013

Silvergate Pharmaceuticals has launched a new drug for treating high blood pressure in children, the company said Monday.

November 1, 2013

Mylan expects to be the first to market with a generic version of a drug for treating patients with gout, the company said Friday, though its filing has triggered a lawsuit from the makers of the branded version.

October 31, 2013

Impax Labs and Tolmar announced that the Food and Drug Administration has given final approval to Tolmar's generic version of Solaraze gel.

October 25, 2013

A Food and Drug Administration expert panel has recommended approval for a drug made by Johnson & Johnson for treating hepatitis C, the company said.

October 25, 2013

The Food and Drug Administration plans to officially recommend that products containing 15 mg or less of the opioid painkiller hydrocodone be rescheduled as Schedule II controlled substances, from the current Schedule III classification. While the idea is to combat abuse and misuse of the drugs, pharmacy groups say the rescheduling would make them harder to obtain for patients who legitimately need them.

The desire to combat abuse and misuse of prescription drugs — now a worse problem in the United States than cocaine or heroin — is laudable, but unlike those two drugs, hydrocodone has a legitimate use as a painkiller, and it's the people who are using it properly and legally who will end up losing.

October 21, 2013

The Food and Drug Administration has approved a pain drug made by Iroko Pharmaceuticals, Iroko said.

October 8, 2013

Lupin Pharmaceuticals announced today that it has launched its generic gatifloxacin ophthalmic solution 0.5%. Lupin had earlier received final approval from the Food and Drug Administration to market a generic version of Allergan's Zymaxid ophthalmic solution, 0.5%, which is indicated for the treatment of bacterial conjunctivitis.