Dr. Reddy’s launches generic acne drug
HYDERABAD, India — Dr. Reddy’s has launched a drug for treating acne, the company said Friday.
The Indian generic drug maker announced the launch of Zenatane (isotretinoin) capsules in the 20-mg and 40-mg strengths. The drug is a therapeutically equivalent generic version of Roche’s Accutane. The Food and Drug Administration also approved the drug in the 10-mg strength.
Various versions of the drug had sales of about $309 million during the 12-month period that ended in January, according to IMS Health.
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FDA proposes regulations for meetings between agency, biosimilar makers
SILVER SPRING, Md. — The Food and Drug Administration is seeking comment from drug makers and others concerning formal meetings between the agency and companies looking to market follow-on biologics.
The agency’s Center for Drug Evaluation and Research announced Friday the release of draft guidance titled "Guidance for Industry: Formal Meetings Between the FDA and Biosimilar Biologic Product Sponsors or Applicants." The agency said the purpose of the guidance was for comment purposes only, and it did not reflect current regulations. An abbreviated approval pathway for follow-on biologics was enacted as part of the Patient Protection and Affordable Care Act of 2010, but regulations have yet to be finalized.
The FDA said the regulations were needed to ensure efficient, consistent procedures for meetings between the agency and drug makers, whether they take place face to face, via teleconference or video conference.
The draft guidance proposes five different types of meetings: Biosimilar Initial Advisory meetings, which discuss the feasibility of a proposed product; Biologic Product Development Type 1 meetings, to discuss issues like clinical holds, special protocols and safety issues; BPD Type 2 meetings, to discuss specific issues such as proposed study designs or study endpoints; BPD Type 3 meetings, which are in-depth data review and advice meetings; and BPD Type 4 meetings, to discuss the format and content of a product application.
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Pharmaca introduces travel vaccination, health consultation program
BOULDER, Colo. — Pharmaca Integrative Pharmacy on Thursday expanded its immunization offering to include travel vaccinations along with a comprehensive list of health services related to traveling abroad.
Pharmaca patients can now schedule an appointment for any of the following vaccinations: hepatitis A and B, tetanus, typhoid, meningitis, Tdap, yellow fever (though not in Colorado locations), varicella and rabies. Pharmaca still offers vaccinations for flu, shingles, whooping cough and pneumonia on a walk-in basis.
Patients can also schedule a pre-travel health consultation with the pharmacist at a cost of $60 for an individual and $100 for a couple. According to the company’s travel site, consultations include help determining which vaccinations are required or recommended for the particular travel destination, a discussion of remedies and best practices for staying healthy while there, a complete report on the destination that includes a detailed summary of pharmacist recommendations around safety and health considerations, and proof of immunizations.