Content about New Drugs & OTCs

ST. LOUIS — Perrigo and a subsidiary of K-V Pharmaceutical Co. have launched a new drug for yeast infections in women, the two companies said.

Perrigo and Ther-Rx Corp. announced the availability of Gynazole-1 (butoconazole nitrate vaginal cream) in the 2% strength for treating yeast infections in nonpregnant women.

Ther-Rx has a partnership with Perrigo to manufacture the drug.

BALTIMORE — The Food and Drug Administration has approved a generic contraceptive made by Lupin Pharmaceuticals, the drug maker said Tuesday.

Lupin announced the approval of levonorgestrel and ethinyl estradiol tablets in the 0.1 mg/0.02 mg strength, a generic version of Watson Labs' Lutera.

Lutera had sales of about $103.6 million during the 12-month period that ended in September 2012, according to IMS Health.

BUFORD, Ga. — "I can't wear this thing." That's the sentiment from some patients when their doctor presents a fracture boot to them after a leg injury. Most often, it's not simply an aesthetic choice. The slight discrepancy in leg length while wearing a fracture boot can cause patients intolerable pain and discomfort. The removable, reusable and adjustable Evenup shoelift equalizes the induced limb-length discrepancy caused by fracture walkers, cast boots or a thick-soled wound-healing shoe.

NEW YORK — A new drug for treating attention deficit hyperactivity disorder made by Pfizer is now available, the drug maker said.

Pfizer announced the availability of Quillivant XR (methylphenidate hydrochloride) extended-release oral suspension, calling it the first once-per-day, extended-release liquid formulation of methylphenidate. The Food and Drug Administration approved the drug in September 2012.

WAYNE, N.J. — The Food and Drug Administration has approved a new intrauterine device for preventing pregnancy made by Bayer HealthCare Pharmaceuticals, the drug maker said.

Bayer announced the approval of Skyla (levonorgestrel-releasing uterine system), which can prevent pregnancy for up to three years. The IUD contains 13.5 mg of levonorgestrel.

Nearly 50% of pregnancies in the United States are unintended, according to the National Center for Health Statistics.

MCHENRY, Ill. — The Calma breastmilk feeding system from Medela, which helps emulate the breastfeeding experience for babies, is now available in major national retail stores, Medela announced Thursday. Calma is a research-based nipple used with a BPA-free breastmilk bottle, designed to help babies maintain their natural feeding behavior and transition from bottle back to breast with ease.

CINCINNATI, Ohio — Drug maker Prasco Labs has launched an authorized generic version of a drug used to treat heavy menstrual bleeding, the company said Monday.

Prasco announced the launch of tranexamic acid tablets in the 650 mg strength, an authorized generic version of Ferring Pharmaceuticals' Lysteda. Authorized generics are branded drugs marketed under their generic names at a discount, usually through third-party companies, to compete with Food and Drug Administration-approved generics.

HYDERABAD, India — Dr. Reddy's Labs has launched a generic drug for treating baldness, the Indian drug maker said.

Dr. Reddy's announced the launch of finasteride tablets in the 1-mg strength, a generic version of Merck's Propecia. As the first company to successfully file for approval of a generic version of the drug, Dr. Reddy's is entitled to 180 days of market exclusivity in which to compete directly with the branded version.

Propecia had sales of about $136 million during the 12-month period that ended in October 2012, according to IMS Health.

WOODCLIFF LAKE, N.J. — Par Pharmaceutical Cos. has started shipping two formulations of a generic drug for treating migraines, the company said.

Par announced the shipment of rizatriptan benzoate tablets and rizatriptan benzoate orally disintegrating tablets in the 5-mg and 10-mg strengths. The drug is used to treat acute migraine with or without aura in patients ages 6 years and older.

The drug has sales of about $653 million per year, according to IMS Health.

PRINCETON, N.J. — The Food and Drug Administration last week approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots in patients with atrial fibrillation that is not caused by a heart valve problem. Eliquis is manufactured by Bristol-Myers Squibb, and marketed by BMS and Pfizer.

SPRING SPRING, Md. — The U.S. Food and Drug Administration on Monday approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection. Diarrhea is experienced by many HIV/AIDS patients and is a common reason why patients discontinue or switch their antiretroviral therapies.

PARSIPPANY, N.J. — Watson Pharmaceuticals on Friday confirmed that Actavis, which was acquired by Watson in October, has filed an abbreviated new drug applications with the U.S. Food and Drug Administration seeking approval to market bortezomib, a generic version of Millennium Pharmaceuticals' Velcade.

Bortezomib is a proteasome inhibitor for intravenous or subcutaneous administration, approved for treatment of patients with multiple myeloma and patients with mantle cell lymphoma who have received at least one prior therapy.