Logo Image
News|Articles|March 1, 2009

FDA actions in brief, March 2009 (Gelnique, RiaSTAP, Kapidex)

Recent FDA approvals (through March 2009) related to Gelnique, RiaSTAP, and Kapidex

Oxybutynin gel 10% (Gelnique, Watson) was approved for the topical treatment of overactive bladder.

Fibrinogen concentrate (human) (RiaSTAP, CSL Behring) was approved for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Dexlansoprazole delayed-release capsules (Kapidex, Takeda) were approved for the once-daily treatment of heartburn associated with symptomatic nonerosive gastroesophageal reflux disease (GERD), the healing of erosive esophagitis (EE), and the maintenance of healed EE.

Related Content

Latest CME

Tumor Board: Expert Insights on Managing Classical 𝘌𝘎𝘍𝘙 Mutations, 𝘌𝘎𝘍𝘙 Exon 20 Insertions, and Atypical 𝘌𝘎𝘍𝘙 Mutations in Metastatic NSCLC
Video

Tumor Board: Expert Insights on Managing Classical 𝘌𝘎𝘍𝘙 Mutations, 𝘌𝘎𝘍𝘙 Exon 20 Insertions, and Atypical 𝘌𝘎𝘍𝘙 Mutations in Metastatic NSCLC

Balazs Halmos, MD, MS; Enriqueta Felip, MD, PhD; Julia Rotow, MD

View more
Medical Crossfire®: Expert Perspectives on Targeting c-Met Overexpression and 𝘔𝘌𝘛 Genomic Alterations in NSCLC – Unveiling the Complexities of 𝘔𝘌𝘛 Dysregulation
Video

Medical Crossfire®: Expert Perspectives on Targeting c-Met Overexpression and 𝘔𝘌𝘛 Genomic Alterations in NSCLC – Unveiling the Complexities of 𝘔𝘌𝘛 Dysregulation

Rebecca Heist, MD, MPH; Alex A. Adjei, MD, PhD, FACP; Sandip Patel, MD, FASCO; Jeremy Segal, MD, PhD

View more
Medical Crossfire®: DLL3-Driven Innovations in Small Cell Lung Cancer – How Do Experts Apply Pivotal Advances to Practice?
Video

Medical Crossfire®: DLL3-Driven Innovations in Small Cell Lung Cancer – How Do Experts Apply Pivotal Advances to Practice?

Jacob Sands, MD; Jennifer Carlisle, MD; Hossein Borghaei, DO, MS

View more
PER Tumor Board®: Applying Recent Advances to Transform the Treatment Paradigm in SCLC—Expert Perspectives on New Approvals and Emerging Strategies
Video

PER Tumor Board®: Applying Recent Advances to Transform the Treatment Paradigm in SCLC—Expert Perspectives on New Approvals and Emerging Strategies

Jonathan W. Goldman, MD; Percy Lee, MD, FASTRO; Erminia Massarelli, MD, PhD, MS; Misty D. Shields, MD, PhD

View more
Medical Crossfire®: The Precision Path for HER2 and TROP2-Targeted Treatments in Non–Small Cell Lung Cancer
Video

Medical Crossfire®: The Precision Path for HER2 and TROP2-Targeted Treatments in Non–Small Cell Lung Cancer

Benjamin P. Levy, MD; Ticiana Leal, MD; Aaron Lisberg, MD; Christine M. Lovly, MD, PhD, FASCO

View more
Oncology Town Hall: From Evidence to Action—Applying KRAS-Targeted Advances in Solid Tumors
Virtual Event

Oncology Town Hall: From Evidence to Action—Applying KRAS-Targeted Advances in Solid Tumors

July 14, 2026

View more
27th Annual International Lung Cancer Congress®
In-Person Event

27th Annual International Lung Cancer Congress®

July 24-25, 2026

Register now!
PER Global Perspectives: The TROP2-Targeted ADC Landscape in NSCLC and How to Interpret the Evidence
Video

PER Global Perspectives: The TROP2-Targeted ADC Landscape in NSCLC and How to Interpret the Evidence

Solange Peters, MD, PhD; Benjamin P. Levy, MD; Tony S.K. Mok, MD, BMSc, FRCP(C), FRCP(Edin), FHKCP, FHKAM(Medicine), FASCO; Maurice Pérol, MD

View more
PER Global Perspectives: Preparing for the Emergence of TROP2 ADCs With Immunotherapy in the Earlier Treatment Settings
Video

PER Global Perspectives: Preparing for the Emergence of TROP2 ADCs With Immunotherapy in the Earlier Treatment Settings

Solange Peters, MD, PhD; Myung-Ju Ahn, MD, PhD; Luis Paz-Ares, MD, PhD; Jacob Sands, MD

View more
PER Global Perspectives: Differentiating and Managing Toxicities with TROP2-Targeted ADCs in NSCLC Through Multidisciplinary Pathways
Video

PER Global Perspectives: Differentiating and Managing Toxicities with TROP2-Targeted ADCs in NSCLC Through Multidisciplinary Pathways

Solange Peters, MD, PhD; Stephanie McDonald, FNP-BC, AOCNP; Antonio Passaro, MD, PhD; Jacob Sands, MD

View more
Breaking Down the Latest Clinical Data for First-line Maintenance and R/R SCLC
Audio

Breaking Down the Latest Clinical Data for First-line Maintenance and R/R SCLC

Rahul Gosain, MD, MBA; Rohit Gosain, MD; Hossein Borghaei, DO, MS

View more
Practical Considerations and Future Directions for New Treatment Strategies in SCLC
Audio

Practical Considerations and Future Directions for New Treatment Strategies in SCLC

Rahul Gosain, MD, MBA; Rohit Gosain, MD; Misty D. Shields, MD, PhD

View more
Navigating Treatment Gaps in SCLC: Relapse, Resistance, and Need for New Options
Audio

Navigating Treatment Gaps in SCLC: Relapse, Resistance, and Need for New Options

Rahul Gosain, MD, MBA; Rohit Gosain, MD; Giannis Mountzios ΜD, PhD

View more
Community Practice Connections™: Distinguishing Precision Pathways for c-Met and MET Alterations in NSCLC
Multimedia

Community Practice Connections™: Distinguishing Precision Pathways for c-Met and MET Alterations in NSCLC

Jonathan Goldman, MD; Erminia Massarelli, MD, PhD, MS; Jorge J. Nieva, MD; Ignacio I. Wistuba, MD

View more
A New Era of Targeted Therapy for Advanced NSCLC: Exploring Future Directions for Bispecific Antibodies and ADCs
Video

A New Era of Targeted Therapy for Advanced NSCLC: Exploring Future Directions for Bispecific Antibodies and ADCs

Sandip Patel, MD, FASCO; Myung-Ju Ahn, MD; Giannis Mountzios, MD, MSc, PhD; Zofia Piotrowska, MD, MHS

View more
26th Annual International Lung Cancer Congress
Video

26th Annual International Lung Cancer Congress

Roy S. Herbst, MD, PhD; Sandip Patel, MD, FASCO; Heather A. Wakelee, MD, FASCO

View more
(CME Track) Antibody–Drug Conjugates in Oncology: The Essentials of AE Management for Better Patient Outcomes
Video

(CME Track) Antibody–Drug Conjugates in Oncology: The Essentials of AE Management for Better Patient Outcomes

Michelle L. Taylor, ANP-BC; Emely Alfaro, DNP, RN, CNS, OCN; Paige Griffith, CRNP; Beth Sandy, MSN, CRNP, FAPO

View more
Community Practice Connections™: Optimizing SCLC Treatment Strategies and Managing Adverse Events Across Disease Stages
Multimedia

Community Practice Connections™: Optimizing SCLC Treatment Strategies and Managing Adverse Events Across Disease Stages

Erminia Massarelli, MD, PhD, MS; Misty D. Shields, MD, PhD

View more
Personalized Approaches in NSCLC: Early Detection, Molecular Testing, and Targeted Therapies
Multimedia

Personalized Approaches in NSCLC: Early Detection, Molecular Testing, and Targeted Therapies

Charu Aggarwal, MD, MPH, FASCO; Zofia Piotrowska, MD, MHS

View more
9th Annual School of Nursing Oncology™
Video

9th Annual School of Nursing Oncology™

Beth Faiman, PhD, MSN, APN-BC, BMTCN, AOCN, FAAN, FAPO; Beth Sandy, MSN, CRNP, FAPO; Lindsay Adkins, MSN, FNP-BC, BMTCN; Jeneth Aquino, DNP, FNP-BC; Casey Gormley, MSN, FNP-C, AOCNP; Heather J. Jackson, PhD, FNP-BC; Kelsey Martin, AG-ACNP-BC, AOCNP; Nerina T. McDonald, PA-C; Lauren Verity Moore, DNP, MSN, AGACNP-BC; Faith A. Mutale, DNP, CRNP; Tiffany Richards, PhD, ANP-BC, AOCNP; Emily Skotte, DNP, MSN, ACNP-BC; Leslie Smith, DNP, RN, APRN-CNS, AOCNS, BMTCN; Saneese Stephen, PA-C, MPAS; Sara M. Tinsley-Vance, PhD, APRN, AOCN

View more
Community Practice Connections™: DLL3-Targeting Bispecific Antibodies for Small Cell Lung Cancer—From Innovation to Practice
Multimedia

Community Practice Connections™: DLL3-Targeting Bispecific Antibodies for Small Cell Lung Cancer—From Innovation to Practice

Jacob Sands, MD; Anne Chiang, MD, PhD

View more
20th Annual New York Lung Cancers Symposium®
Video

20th Annual New York Lung Cancers Symposium®

Balazs Halmos, MD, MS; Jamie Chaft, MD

View more
Cases and Conversations™: Transforming Small Cell Lung Cancer Treatment Through Emerging Evidence and Expert Insights
Video

Cases and Conversations™: Transforming Small Cell Lung Cancer Treatment Through Emerging Evidence and Expert Insights

Charles M. Rudin, MD, PhD; Anne Chiang, MD, PhD, FASCO; Jacob M. Sands, MD

View more
Hot Seat: Converging Lines in the Management of RAS-Altered Cancers
Video

Hot Seat: Converging Lines in the Management of RAS-Altered Cancers

Shubham Pant, MD, MBBS; Alison Schram, MD; Helena Yu, MD

View more
From Clue to Care: Rapid Recognition and Coordinated Management of Paraneoplastic LEMS in SCLC
Video

From Clue to Care: Rapid Recognition and Coordinated Management of Paraneoplastic LEMS in SCLC

Millie Das, MD; Wade Iams, MD, MSCI; Ruham Nasany, MD

View more
From Suspicion to Stabilization: Early Recognition and Treatment of Paraneoplastic LEMS
Video

From Suspicion to Stabilization: Early Recognition and Treatment of Paraneoplastic LEMS

Charu Aggarwal, MD, MPH, FASCO; Erminia Massarelli, MD, PhD, MS; Ruham Nasany, MD

View more