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Executive Summary

FDA is highlighting 14 of 113 biologics approved during the year as "important" approvals. Among the therapies cited in FDA's annual summary of approval actions are Amgen's Epogen (epoetin alfa), SmithKline Beecham's Eminase (anistreplase), SmithKline's recombinant Nepatitis b vaccine Energix-B, and Interferon Science's Alferon-N (interferon alfa-3). FDA also highlighted two year-end approvals: Merck's Haemophilus influenzae b conjugate vaccine PedvaxHIB and Berkeley, California-based Oculinum, Inc.'s orphan botulinum toxin type A injection Oculinum. The botulinum toxin will be marketed by Allergan. Approved on Dec. 20, PedvaxHIB is indicated for prevention of bacterial meningitis in children 18 months to five years old. The company is expected to announce launch plans for the vaccine the week of Jan. 8. Merck, which filed a PLA for PedvaxHIB in August 1988, had hoped to get approval for use of the vaccine in children as young as 12 months of age. However, the vaccine was approved for the same age range as the two other marketed Haemophilus b conjugate vaccines: Connaught's ProHIBIT, approved in December 1987, and Praxis Biologics' HibTITER, approved at the end of 1988. Merck said that PedvaxHIB labeling permits use in children 15 months of age in certain cases. Both Praxis and Connaught have PLAs filed for use of their vaccines in infants, and Merck is in clinicals for the expanded indication. FDA approved Oculinum, an eye muscle treatment, on Dec. 29. The PLA was submitted in 1985. Oculinum is indicated "for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or [seventh] nerve disorders in patients 12 years of age and above," labeling states. Allergan estimates that 25,000 people suffer from blepharospasm and 5-10,000 adults have strabismus, although the majority of patients with that disorder are children. Shipments of Oculinum are anticipated to begin "in approximately 30 days," Allergan said. The product will be shipped directly to physicians qualified to administer the biological, such as ophthalmologists and neurologists. The injectable product must by shipped frozen via overnight delivery. Letters to physicians announcing the product are expected to be sent out the week of Jan. 8. Under the agreement with Allergan, Oculinum will manufacture the biological. The biologic received orphan drug status in 1984, and the FDA release notes that the product has been supplied "to more than 200 physicians...for experimental treatments."

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