November 2015

Dr. Reddy's Laboratories announced that it has completed the purchase of worldwide exclusive intellectual property rights for Fondaparinux sodium, its generic anti-coagulant drug, from its Australian partner, Alchemia Limited. Earlier, the company had signed a term sheet for this transaction in September, 2015.

Mylan  announced the U.S. launch of Nevirapine Extended-release Tablets, 100 mg, the generic version of Boehringer Ingelheim's Viramune XR®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is used in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in children 6 to less than 18 years of age. The launch adds to Mylan's growing portfolio of ARV medicines across the globe, and represents the company's continued commitment to stem the tide of HIV/AIDS. Nearly 50% of those being treated for HIV/AIDS in the developing world, for example, rely on a Mylan product.

Mylan N.V. announced the U.S. launch of Glipizide Extended-release Tablets, 5 mg and 10 mg, the generic version of Pfizer's GLUCOTROL XL®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Collegium Pharmaceutical, Inc.  announced that the United States Food and Drug Administration (FDA) has granted tentative approval to the Company's New Drug Application (NDA) for Xtampza™ ER (oxycodone) extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

In what can be a shot in the arm for the field of cognitive science, the Ministry of Science and Technology has come up with screening tools for early detection of dyslexia in four different languages. The assessment of dyslexia is carried out using a series of age-appropriate, culturally-valid psychological tests in the child's native language - Hindi, English, Kannada and Marathi. Scientists working on the project said nearly 70 to 80 per cent of students are diagnosed with Learning Disorders (LDs). Dyslexia is the most common learning disability with almost 35 million children in the country suffering from it.