Regulatory and Washington

NEW YORK — The Food and Drug Administration has approved a new treatment for a rare genetic disorder that affects 10,000 people worldwide.

Pfizer and Protalix BioTherapeutics announced Wednesday the approval of Elelyso (taliglucerase alfa), an enzyme-replacement therapy for the long-term treatment of Type 1 Gaucher disease.

ATLANTA — The Food and Drug Administration has approved a generic drug for epilepsy made by Acella Pharmaceuticals, the company said Wednesday.

Acella announced the approval of gabapentin oral solution in the 250-mg-per-5-mL strength. The drug is a generic version of Parke Davis' Neurontin.

DEERFIELD, Ill. — With new Massachusetts state regulations allowing pharmacists to administer a broad range of immunizations, Walgreens has significantly expanded vaccine availability at all of its 165 locations across the state, and now is offering immunizations daily for 12 vaccines currently recommended by the Centers for Disease Control and Prevention, the retail pharmacy operator announced Wednesday.
  

WASHINGTON — The philanthropic arm of the American Pharmacists Association has announced this year's recipients of an award that recognizes pharmacists who increase medication adherence, reduce drug misadventures and promote the use of national treatment guidelines.

PITTSBURGH — Generic drug maker Mylan has released a version of a drug used to treat bacterial infections, the company said.

Mylan announced the launch of doxycycline hyclate delayed-release tablets in the 150-mg strength. The launch follows a decision by the U.S. District Court for the District of New Jersey that Mylan's product did not infringe patents covering the drug's branded version, Doryx. Warner Chilcott, which markets Doryx, had brought the case.

NEW YORK — An online plea for help from a mother dying of breast cancer prompted the manufacturer of an experimental drug to release it early, according to published reports.

In an article posted on its website, CNN told the story of 46-year-old Darlene Gant, a woman with stage-four breast cancer, as she wrote letters to be given to her 11-year-old son on his upcoming birthday, and at future events, such as his high school and college graduations and marriage.

WHITEHOUSE STATION, N.J. — Mylan will be barred from marketing a generic version of a Merck cardiovascular drug until the drug's patent expires, under a court ruling announced Friday.

Merck said the U.S. District Court for the District of New Jersey ruled against Mylan in two patent infringement suits related to the drugs Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin). Specifically, the court ruled that a patent covering the drug, RE 42,461, is valid and enforceable and enjoined Mylan from launching until the patents expiration in April 2017.

PITTSBURGH — Mylan plans to start selling a generic version of a drug for sleep disorders starting in June 2016, under a deal with Teva announced Monday.

Mylan said it had settled with Teva over the former's generic version of Nuvigil (armodafinil) tablets, a drug used to treat sleepiness related to sleep apnea, narcolepsy and shift work disorder.