New Products

PITTSBURGH — Mylan subsidiary Bioniche Pharma has launched an injectable treatment for a rare metabolic disorder, Mylan said Tuesday.

Mylan announced the launch of octreotide acetate injection in prefilled syringes, a generic version of Novartis’ Sandostatin, used to treat the disorder acromegaly and suppress or inhibit severe diarrhea related to certain tumors. Acromegaly results from excess growth hormone produced in the pituitary gland, causing fatigue and weakness, body odor and carpal tunnel syndrome.

RIDGEFIELD, Conn. — The Food and Drug Administration has approved Boehringer Ingelheim Pharmaceuticals' single-pill antiretroviral for HIV-1 patients, BI said Tuesday.

The FDA approved Viramune XR (nevirapine), a single-pill, once-daily, extended-release formulation of nevirapine for use in combination with other antiretroviral drugs.

NEW YORK — French skin care brand Vichy Labs will launch in May its new ProEven total dark spot corrector, a formula with DeeperCell-concentrate designed to help address dark spots and uneven skin tone.

HAYWARD, Calif. — Generic drug maker Impax Labs is hoping to become the first to market a version of a gastroesophageal reflux disease treatment made by Takeda Pharmaceutical.

Impax said Tuesday that it had filed an approval application with the Food and Drug Administration for dexlansoprazole delayed-release capsules in the 30-mg and 60-mg strengths. The drug is a version of Takeda’s Dexilant.

WESTBURY, N.Y. — PL Developments on Monday announced that it has acquired the exclusive rights to sell and distribute store-brand over-the-counter versions of omeprazole sodium bicarbonate capsules, the generic version of Merck’s Zegerid OTC.

Par Pharmaceutical currently has approval for the prescription product and has filed for the OTC version. Upon FDA approval and upon favorable resolution of intellectual property litigation, PL Developments will begin marketing the new store-brand proton-pump inhibitor, the company stated.

INDIANAPOLIS — A topical medication for treating low testosterone in men now is available, drug maker Eli Lilly said.

Lilly announced the availability of Axiron (testosterone), a topical solution designed for application under the arm.

The Food and Drug Administration approved Axiron in November, making it the only testosterone replacement therapy applied to the underarm.

NEW YORK — CandyRific is boosting Mike and Ike candy offerings with new items.

BEDMINSTER, N.J. — A drug used to treat pain in cancer patients now is available in the United States.

ProStrakan Group announced Monday the launch of Abstral (fentanyl) sublingual tablets. The tablets, which disintegrate rapidly and are placed under the tongue, treat breakthrough pain, common in one-half to two-thirds of people with cancer-related pain.

The drug, an opioid and controlled substance, only is available through a Food and Drug Administration-mandated REMS program. The FDA approved the drug in January.