Capsules. Life-threatening allergy - FDA nod for generic EpiPen

The US Food and Drug Administration has approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and paediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths. FDA Commissioner Scott Gottlieb said “This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages. The path to developing generic drug-device combination products like this one is challenging. We remain committed to doing our part to provide scientific and regulatory clarity for sponsors seeking to develop complex generics, as well as prioritize the approval of medicines with little or no generic competition as part of our overarching effort to remove barriers to generic development and market entry of critically important medicines,” he added.

Life-threatening allergies can include reactions to insect bites or stings, foods, medications, latex or other causes. Anaphylaxis is a medical emergency that affects the whole body and, in some cases, leads to death. The EpiPen is intended to automatically inject a dose of epinephrine into a person’s thigh to stop an allergic reaction.

Eating carbohydrates in moderation seems to be optimal for health and longevity, suggests new research published in The Lancet Public Health journal.

The observational study of more than 15,400 people from the Atherosclerosis Risk in Communities Study (ARIC) in the US found that diets both low (< 40 per cent energy) and high (>70 per cent energy) in carbohydrates were linked with an increase in mortality, while moderate consumers of carbohydrates (50–55 per cent of energy) had the lowest risk of mortality. The primary findings, confirmed in a meta-analysis of studies on carbohydrate intake including more than 432,000 people from over 20 countries, also suggest that not all low-carbohydrate diets appear equal — eating more animal-based proteins and fats from foods like beef, lamb, pork, chicken and cheese instead of carbohydrate was associated with a greater risk of mortality. Alternatively, eating more plant-based proteins and fats from foods such as vegetables, legumes, and nuts was linked to lower mortality, a note from the journal said.

AstraZeneca Pharma India Ltd has received import and market permission for olaparib (Lynparza® )100 mg and 150 mg tablets in India by the Drug Controller General of India (DCGI), it said.

The permission paves the way for the launch of olaparib (Lynparza®) in India, subject to the receipt of further related statutory approvals and licences. Olaparib (Lynparza®) is a patented product of the AstraZeneca group.

Gagan Singh, AZ (India) Managing Director, said, “The import and market permission for olaparib is a significant milestone for women in India living with platinum-sensitive relapsed ovarian cancer and BRCA-mutated HER-2 negative metastatic breast cancer, which have historically been difficult-to-treat diseases. This approval will bring this innovative, targeted option that may help to delay disease progression for these patients.”

Breast and ovarian cancers are the leading causes of cancer-related deaths in women of India. As per three-year report of population based cancer registries-2012-2014 in India, ovarian cancer is the third leading site of cancer among women, trailing behind breast and cervical cancer.

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