Content about New Drugs & OTCs

January 6, 2014

Amneal Pharmaceuticals has launched an authorized generic version of a recently launched drug for gastroesophageal reflux disease, the company said.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched an authorized generic version of a recently launched drug for gastroesophageal reflux disease, the company said Monday.

January 3, 2014

Teva Pharmaceutical Industries has launched an authorized generic version of a drug used to treat overactive bladder, the company said Friday.

JERUSALEM — Teva Pharmaceutical Industries has launched an authorized generic version of a drug used to treat overactive bladder, the company said Friday.

January 2, 2014

Drug maker Eisai will make a new epilepsy drug available in the United States starting on Monday, the company said.

WOODCLIFF LAKE, N.J. — Drug maker Eisai will make a new epilepsy drug available in the United States starting on Monday, the company said Thursday.

December 18, 2013

Actelion has launched a topical gel used to treat a kind of skin cancer, the company said.

SOUTH SAN FRANCISCO, Calif. – Actelion has launched a topical gel used to treat a kind of skin cancer, the company said.

Actelion announced the launch of Valchlor (mechlorethamine), which the Food and Drug Administration approved in August for treating stage 1A and 1B mycosis fungoides-type cutaneous T-cell lymphoma in patient who have received skin-directed therapy before. Actelion acquired rights to the drug when it merged with Ceptaris Therapeutics. Accredo Specialty Pharmacy distributes the drug in the United States.

December 18, 2013

The Food and Drug Administration has approved a new drug made by GlaxoSmithKline and Theravance for treating chronic obstructive pulmonary disease, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by GlaxoSmithKline and Theravance for treating chronic obstructive pulmonary disease, the agency said Wednesday.

The FDA announced the approval of Anoro Ellipta (umeclidinium; vilanterol inhalation powder) as a once-per-day maintenance treatment for airflow obstruction in patients with COPD, a term that encompasses chronic bronchitis and emphysema; smoking is the leading cause of COPD in the United States.

December 18, 2013

Lupin has launched a generic drug for treating HIV, following its victory in a patent-infringement suit in federal court, the Indian drug maker said Wednesday.

BALTIMORE — Lupin has launched a generic drug for treating HIV, following its victory in a patent-infringement suit in federal court, the Indian drug maker said Wednesday.

Lupin's U.S. subsidiary launched its generic version of ViiV Healthcare's Trizivir (abacavir sulfate; lamivudine; zidovudine) tablets in the 300-mg/150-mg/300-mg strength. The launch follows a ruling by the U.S. District Court for the District of Delaware that the drug did not infringe on Viiv's patent.

December 17, 2013

Amneal Pharmaceuticals has launched a new treatment for gastroesophageal reflux disease under a partnership with a South Korean drug maker.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched a new treatment for gastroesophageal reflux disease under a partnership with a South Korean drug maker.

Amneal announced Tuesday the launch of esomeprazole strontium delayed-release capsules in the 49.3-mg strength, which it is marketing in the United States under a contract with Hanmi Pharmaceutical Co. The drug is expected to begin shipping Wednesday in 30-count bottles.

December 17, 2013

Greenstone has launched a version of a drug used to treat fungal infections, the company said.

PEAPACK, N.J. — Greenstone has launched a version of a drug used to treat fungal infections, the company said.

Greenstone, the generics subsidiary of Pfizer, announced the introduction of voriconazole for oral suspension, an authorized generic version of Pfizer's Vfend. Authorized generics are branded drugs sold at a discount under their generic names.

Greenstone is selling the drug in the 40 mg-per-milliliter strength. Vfend had sales of about $17.1 million during the 12-month period that ended in June, according to IMS Health.

 

December 16, 2013

A redesigned version of an injector pen used to treat infertility is available for distribution in the United States, the manufacturer said.

ROCKLAND, Mass. — A redesigned version of an injector pen used to treat infertility is available for distribution in the United States, the manufacturer said Monday.

EMD Serono, a subsidiary of German drug maker Merck KGaA, said that Gonal-f RFF Redi-ject, a disposable, pre-filled pen used for the drug Gonal-f RFF (follitropin alfa), had become available. The Food and Drug Administration approved the redesigned pen in October. Merck KGaA operates in the United States under the name EMD in order to avoid confusion with U.S.-based Merck & Co.

December 12, 2013

A panel of experts at the Food and Drug Administration has recommended approval for an experimental biotech drug under development by Bristol-Myers Squibb and AstraZeneca for a group of rare metabolic disorders.

PRINCETON, N.J. — A panel of experts at the Food and Drug Administration has recommended approval for an experimental biotech drug under development by Bristol-Myers Squibb and AstraZeneca for a group of rare metabolic disorders.

December 12, 2013

Kaz announced the launch of the Braun Forehead Thermometer, which features a lightweight, ergonomic design, providing a step-by-step on-product usage guide and user-facing digital temperature readouts on a large, backlit screen.

SOUTHBOROUGH, Mass. — Kaz on Thursday announced the launch of the Braun Forehead Thermometer, which features a lightweight, ergonomic design, providing a step-by-step on-product usage guide and user-facing digital temperature readouts on a large, backlit screen. 

In addition, the thermometer's fever guidance system indicates the severity of each reading with a green, yellow or red light, helping parents easily decipher and monitor the status of their child's temperature. 

December 11, 2013

The Food and Drug Administration has approved the first generic versions of a drug used to treat depression and other conditions, the agency said.

SILVER SPRING, Md. – The Food and Drug Administration has approved the first generic versions of a drug used to treat depression and other conditions, the agency said Wednesday.

The FDA announced the approval of generic duloxetine delayed-release capsules manufactured by Aurobindo Pharma, Dr. Reddy's Labs, Lupin, Sun Pharmaceutical Industries, Teva Pharmaceutical Industries and Torrent Pharmaceuticals.

December 10, 2013

An expert panel at the Food and Drug Administration has given a thumbs-up to an experimental drug made by Takeda Pharmaceutical Co. for treating ulcerative colitis and Crohn's disease, the drug maker said.

DEERFIELD, Ill. — An expert panel at the Food and Drug Administration has given a thumbs-up to an experimental drug made by Takeda Pharmaceutical Co. for treating ulcerative colitis and Crohn's disease, the drug maker said.

December 6, 2013

Teva Pharmaceutical Industries' U.S. subsidiary has launched a generic drug for treating warts and skin lesions, the company said.

NORTH WALES, Pa. — Teva Pharmaceutical Industries' U.S. subsidiary has launched a generic drug for treating warts and skin lesions, the company said.

Teva Pharmaceuticals announced the launch and availability of imiquimod cream, a generic version of Medicis Pharmaceutical Corp.'s Aldara.

The drug is used to treat external genital and rectal warts, certain types of actinic keratosis and basal cell carcinoma. Various versions of the drug had sales of about $244 million in 2011, according to IMS Health.

 

December 5, 2013

Mylan has launched a generic drug for treating a condition that causes heightened levels of the protein prolactin in the blood, the company said Thursday.

PITTSBURGH — Mylan has launched a generic drug for treating a condition that causes heightened levels of the protein prolactin in the blood, the company said Thursday.

Mylan announced the launch of cabergoline tablets in the 0.5-mg strength, used for treating hyperprolactinemic disorders.

Various versions of the drug had sales of about $41.67 million during the 12-month period ending in September, according to IMS Health.

 

December 4, 2013

The Food and Drug Administration has approved a new topical drug for treating scars made by Oculus Innovative Sciences, the drug maker said Wednesday.

PETALUMA, Calif. — The Food and Drug Administration has approved a new topical drug for treating scars made by Oculus Innovative Sciences, the drug maker said Wednesday.

The FDA has approved Microcyn scar-management hydrogel, used to treat scars resulting from burns, surgery and trauma wounds. Oculus and a partnering company, Quinnova Pharmaceuticals, intend to start selling the drug in the first half of next year.

December 3, 2013

The Food and Drug Administration has given tentative approval to a generic drug used to treat prostate disease, agency records showed.

SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to a generic drug used to treat prostate disease, agency records showed.

The FDA granted tentative approval to Roxane Labs' dutasteride capsules in the 0.5-mg strength. The drug is a generic version of GSK's Avodart, used to treat benign prostatic hyperplasia.

Tentative approval means that a drug meets the agency's conditions for approval, but can't receive final approval until Avodart loses its patent protection, which will occur in 2015.

 

December 2, 2013

Shionogi and Egalet have entered a deal worth up to $425 million for the development of abuse-deterrent opioid painkillers, Egalet said.

MALVERN, Pa. — Shionogi and Egalet have entered a deal worth up to $425 million for the development of abuse-deterrent opioid painkillers, Egalet said.

The deal centers on the development and potential commercialization of experimental drugs containing the opioid painkiller hydrocodone.

December 2, 2013

The Food and Drug Administration has approved a generic version of a drug for schizophrenia and bipolar disorder made by Jubilant Life Sciences, the Indian drug maker said.

NOIDA, India — The Food and Drug Administration has approved a generic version of a drug for schizophrenia and bipolar disorder made by Jubilant Life Sciences, the Indian drug maker said.

Jubilant announced the approval of quetiapine fumarate tablets in the 25-mg strength. The drug is a generic version of AstraZeneca's Seroquel.

Various versions of the drug have annual sales of about $59 million, according to IMS Health.

 

December 2, 2013

Sandoz will market an authorized generic version of an attention deficit hyperactivity disorder drug made by Shire under a contract between the two companies, Shire said Monday.

PHILADELPHIA — Sandoz will market an authorized generic version of an attention deficit hyperactivity disorder drug made by Shire under a contract between the two companies, Shire said Monday.

Shire said Sandoz, the generics division of Swiss drug maker Novartis, would market an authorized generic version of Adderall XR (amphetamine; dextroamphetamine).

November 26, 2013

The Food and Drug Administration has approved a new tablet form of an antifungal drug made by Merck, the company said Tuesday.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a new tablet form of an antifungal drug made by Merck, the company said Tuesday.

Merck announced the FDA approval of Noxafil (posaconazole) 100-mg delayed release tablets. The company also markets a 40-mg-per-milliliter oral suspension form of the drug. The new tablet formulation is designed to be taken in two 300-mg doses on the first day, followed by a 300-mg dose once per day.

November 25, 2013

The Food and Drug Administration has approved a new treatment made by Johnson & Johnson for hepatitis C, the drug maker said.

TITUSVILLE, N.J. — The Food and Drug Administration has approved a new treatment made by Johnson & Johnson for hepatitis C, the drug maker said.

November 25, 2013

Pfizer on Monday launched Robitussin Maximum Strength Cough + Congestion DM, a new liquid-filled capsule that helps control cough on-the-go.

MADISON, N.J. — Pfizer on Monday launched Robitussin Maximum Strength Cough + Congestion DM, a new liquid-filled capsule that helps control cough on-the-go. "This formulation not only harnesses the power of Maximum Strength Robitussin cough liquid, but is a convenient option for those hitting the road or boarding a plane this holiday season," the company stated.

The company noted that whether traveling cross country or staying close to home, families can track when cough activity spikes in their local area via the Robitussin COUGHCAST tool. 

November 22, 2013

The Food and Drug Administration has approved a drug made by Bayer HealthCare Pharmaceuticals for treating thyroid cancer, the agency said Friday.

SILVER SPRING, Md. – The Food and Drug Administration has approved a drug made by Bayer HealthCare Pharmaceuticals for treating thyroid cancer, the agency said Friday.

The FDA announced the approval of Nexavar (sorafenib) to treat late-stage differentiated thyroid cancer. The drug was already approved for kidney and liver cancers. The drug works by limiting cancer cell growth and replication by inhibiting proteins within the cells.

November 22, 2013

Teva Pharmaceutical Industries has launched its generic version of a drug for patients with cystic fibrosis, the Israeli drug maker said Thursday.

JERUSALEM — Teva Pharmaceutical Industries has launched its generic version of a drug for patients with cystic fibrosis, the Israeli drug maker said Thursday.

Teva announced the launch of tobramycin inhalation solution, a generic version of Novartis' drug Tobi. The Food and Drug Administration approved Teva's product last month. The drug is used to treat CF in patients whose lungs contain bacteria called Pseudomonas aeroginosa.

Tobi had sales of about $350 million during the 12-month period that ended in June, according to IMS Health.